Note: This page contains sample records for the topic nda efficacy supplement from Science.gov.
While these samples are representative of the content of Science.gov,
they are not comprehensive nor are they the most current set.
We encourage you to perform a real-time search of Science.gov
to obtain the most current and comprehensive results.
Last update: November 12, 2013.
1

CLINICAL TEAM LEADER REWIEW OF NDA EFFICACY ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... ODAC Briefing Document Tarceva® (erlotinib) FDA Briefing Document ... December 16, 2009 NDA 21743/S016 Tarceva® (erlotinib) tablets oral ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

2

New Drug Application (NDA) Efficacy Supplements Calendar ...  

Center for Drug Evaluation (CDER)

... AND PATIENT PACKAGE INSERT WITH THE 48 WEEK DATA FROM ... DOSING RECOMMENDATIONS FOR PATIENTS AGED 4 WEEKS TO LESS ... More results from www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved

3

Prompt Review of Priority Efficacy Supplements  

Center for Drug Evaluation (CDER)

Text Version... Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements ... Efficacy Supplements, Including ... More results from www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation

4

Application Type Supplemental NDA 20-363 Submission ...  

Center for Drug Evaluation (CDER)

Text Version... Review Andreas Pikis, MD sNDA 20-363/SN036 ... Twenty-two of the 25 subjects were ... Pharmacokinetic results: Penciclovir exposures after a single ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

5

New Drug Application (NDA) & Biologic License Application ...  

Center for Drug Evaluation (CDER)

Text VersionPage 1. New Drug Application (NDA) & Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals As of December 31, 2010 ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

6

Geriatric Use Supplement Clinical Efficacy Trials Category  

Center for Drug Evaluation (CDER)

... Geriatric Use Supplement Clinical Efficacy Trials Category. FDA Data Element Number. ... Geriatric Use Supplement Clinical Efficacy Trials Category. ... More results from www.fda.gov/drugs/developmentapprovalprocess/formssubmissionrequirements

7

NDA 21-530/20-938 Meloxicam Oral Suspension: BPCA ...  

Center for Drug Evaluation (CDER)

Text Version... age and older NDA Type: Efficacy Supplement Pediatric Written Request Sponsor: Boehringer Ingelheim Primary Reviewer: Chandra S. Chaurasia ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

8

BLA EFFICACY SUPPLEMENT MEDICAL FINAL REVIEW ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... EFFICACY SUPPLEMENT BASED ON POST MARKETING COMMITMENT ROUTINE ... frequency of bleeding episodes in adults and children (0-16 ... More results from www.fda.gov/downloads/biologicsbloodvaccines/bloodbloodproducts

9

Efficacy of nutritional supplements used by athletes.  

PubMed

Findings on the efficacy of nutritional supplements used by athletes are reviewed. Many athletes have turned away from anabolic steroids and toward nutritional supplements in the hope of gaining a competitive edge without threatening their health. Athletes may require slightly more protein than sedentary people do to maintain positive nitrogen balance, but it is dubious whether extra dietary protein will help someone to achieve athletic goals. Purified amino acids have become a popular if expensive form of protein supplementation; there is no scientific evidence, however, to support their use. Excessive protein supplementation can lead to dehydration, gout, liver and kidney damage, calcium loss, and gastrointestinal effects. Supplementation with vitamins and minerals in excess of recommended daily allowances appears to have no effect on muscle mass or athletic performance. Other substances touted as having ergogenic properties are carnitine, cobamamide, growth hormone releasers, octacosanol, and ginseng; again, there is no reliable scientific evidence to support claims that products containing these compounds have ergogenic potential, and heavy supplementation may lead to adverse effects. Nutritional supplements are promoted through unsubstantiated claims by magazine advertisements, health food stores, coaches, and other sources. The FDA considers nutritional supplements to be foodstuffs, not drugs, and therefore has not required that they be proved safe and effective. Dosage guidelines are inadequate, and quality control is poor. The FDA has begun to revise regulations governing labeling and health claims for these products. There is little if any evidence that nutritional supplements have ergogenic effects in athletes consuming a balanced diet, and some products have the potential for harm. PMID:8137607

Beltz, S D; Doering, P L

1993-12-01

10

Efficacy of over-the-counter nutritional supplements  

Microsoft Academic Search

More than 100 million people in the United States report using nutritional supplements. Most people are under the impression\\u000a that nutritional supplements offer health benefits and are closely regulated to ensure safety and efficacy. Unfortunately,\\u000a the Dietary Supplement Health and Education Act of 1994 allows for the promotion of nutritional supplements without review\\u000a by the United States Food and Drug

Michael H. Davidson; Chris T. Geohas

2003-01-01

11

Efficacy of over-the-counter nutritional supplements.  

PubMed

More than 100 million people in the United States report using nutritional supplements. Most people are under the impression that nutritional supplements offer health benefits and are closely regulated to ensure safety and efficacy. Unfortunately, the Dietary Supplement Health and Education Act of 1994 allows for the promotion of nutritional supplements without review by the United States Food and Drug Administration; therefore, it is important to evaluate the efficacy and safety of these supplements. There is strong scientific evidence supporting the use of plant sterols/stanols, omega-3 fatty acids, niacin, folate, vitamin B(6)/B(12), and tree nuts. There is potential evidence for the health benefits of soy protein, tea extracts, policosanol, guggulipids, coenzyme Q10, and L-arginine. There has been a lack of evidence for the health benefits of garlic and antioxidants. PMID:12562537

Davidson, Michael H; Geohas, Chris T

2003-01-01

12

Dietary Supplements During Pregnancy: Need, Efficacy and Safety  

Microsoft Academic Search

National surveys indicate that as many as 97% of women living in the United States are advised by their health care providers\\u000a to take multivitamin, multimineral (MVMM) supplements during pregnancy, and 7–36% of pregnant women use botanical supplements\\u000a during this time. Although there is evidence of benefit from some of these preparations, efficacy has not been established\\u000a for most of

Mary Frances Picciano; Michelle Kay McGuire

13

Efficacy of chromium-yeast supplementation for growing beef steers  

Microsoft Academic Search

This experiment was conducted to determine the efficacy of feeding chromium yeast to growing beef steers. Animal growth, gain efficiency, and blood glucose kinetics were determined in 24 beef steers (initial body weight=253 ±4kg) fed a corn silage-based diet supplemented with 0 (control), 100, 200, or 400?g chromium from high-chromium yeast\\/kg of diet dry matter. Intravenous glucose tolerance tests (IVGTT)

K. C Swanson; D. L Harmon; K. A Jacques; B. T Larson; C. J Richards; D. W Bohnert; S. J Paton

2000-01-01

14

NDA 20-634/S-047 SUPPLEMENTAL NDA APPROVAL NDA ...  

Center for Drug Evaluation (CDER)

Text Version... talk to your health care professional before taking this medication. LEVAQUIN ... LETTERS TO HEALTH CARE PROFESSIONALS ... More results from www.fda.gov/downloads/drugs/emergencypreparedness

15

Multivitamin-mineral supplementation is not as efficacious as is iron supplementation in improving hemoglobin concentrations in nonpregnant anemic women living in Mexico1-4  

Microsoft Academic Search

Background: Iron supplements improve hemoglobin status and reduce anemia due to iron deficiency. It is not known whether mul- tiple micronutrient (MM) supplements are as efficacious as are iron supplements alone in improving hemoglobin concentrations. Objective: We conducted a randomized, double-blind community trial in Mexico to compare the efficacy of MM supplements con- taining iron with that of iron alone

Siobhan E Moriarty-Craige; Usha Ramakrishnan; Lynnette Neufeld; Juan Rivera; Reynaldo Martorell

16

Efficacy and mechanism of action of turmeric supplements in the treatment of experimental arthritis  

Microsoft Academic Search

Objective. Scientific evidence is lacking for the antiarthritic efficacy of turmeric dietary supplements that are being promoted for arthritis treatment. There- fore, we undertook studies to determine the antiarthritic efficacy and mechanism of action of a well-characterized turmeric extract using an animal model of rheumatoid arthritis (RA). Methods. The composition of commercial tur- meric dietary supplements was determined by high-

Janet L. Funk; Jennifer B. Frye; Janice N. Oyarzo; Nesrin Kuscuoglu; Jonathan Wilson; Gwen McCaffrey; Gregory Stafford; Guanjie Chen; R. Clark Lantz; Shivanand D. Jolad; Aniko M. Sólyom; Pawel R. Kiela; Barbara N. Timmermann

2006-01-01

17

Ridaforolimus NDA 22576  

Center for Biologics Evaluation and Research (CBER)

Text Version... Ridaforolimus NDA 22576 Clinical Reviewer: Gwynn Ison, MD Statistical Reviewer: Huanyu Chen, PhD ... Clinical Gwynn Ison Ellen Maher Statistics ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

18

Safety, Efficacy, and Legal Issues Related to Dietary Supplements  

ERIC Educational Resources Information Center

This article focuses on the effects of dietary supplements on collegiate and adult populations. Anabolic steroids, amphetamines, and other drugs have been used for decades to improve athletic performance. However, the legal issues and dangers associated with these drugs have resulted in reluctance by many athletes to use them. Because dietary…

Powers, Michael

2004-01-01

19

Safety, Efficacy, and Legal Issues Related to Dietary Supplements  

ERIC Educational Resources Information Center

|This article focuses on the effects of dietary supplements on collegiate and adult populations. Anabolic steroids, amphetamines, and other drugs have been used for decades to improve athletic performance. However, the legal issues and dangers associated with these drugs have resulted in reluctance by many athletes to use them. Because dietary…

Powers, Michael

2004-01-01

20

Efficacy of defatted soy flour supplement in Gulabjamun  

Microsoft Academic Search

Study was undertaken to determine the efficacy of defatted soyflour mix levels in Gulabjamun (sweet dessert comprised of fried milk balls dipped in sugar syrup) and its impact on the quality parameters. Soy flour was fortified in three levels (3.33, 6.66 and 9.99%) w\\/w to prepare different compositions of Gulabjamuns by replacing wheat-flour in control recipe. 10 g spherical shape

Awadhesh Kumar Singh; Dattatreya Mahadev Kadam; Mili Saxena; R. P. Singh

21

Anesthetic efficacy of the supplemental intraosseous injection of 3% mepivacaine in irreversible pulpitis  

Microsoft Academic Search

Objective. To determine the efficacy of a supplemental intraosseous injection of 3% mepivacaine in mandibular posterior teeth with irreversible pulpitis. Intraosseous injection pain, subjective heart rate increase, and pain ratings during endodontic treatment were also assessed.Study Design. Forty-eight patients with irreversible pulpitis received conventional inferior alveolar nerve blocks. Electric pulp testing was used to determine pulpal anesthesia. Patients who were

Deron Reisman; Al Reader; Robert Nist; Mike Beck; Joel Weaver

1997-01-01

22

Efficacy of garlic supplementation in lowering serum cholesterol levels.  

PubMed

Previous studies using garlic have found alterations on a number of cardiovascular disease (CVD) risk factors including blood pressure, plasma viscosity, platelet activity, and serum lipid levels. The latest clinical research suggests that consumption of garlic powder does not play a significant role in lowering plasma lipid levels when in conjunction with a low-fat, low-cholesterol diet. Additional well-controlled, long-term studies that explore dosage and preparation type are necessary to confirm the efficacy of garlic in lowering cholesterol levels and to fully understand garlic's potential role in CVD. PMID:11475449

Spigelski, D; Jones, P J

2001-07-01

23

Evidence of clinically relevant efficacy for dietary supplements and nutraceuticals.  

PubMed

Beyond the well-known effects on blood pressure (BP) of the DASH and the Mediterranean diets, a large number of studies have investigated the possible a BP-lowering effect from different dietary supplements and nutraceuticals, mostly antioxidant agents with a high tolerability and safety profile. In particular, a relatively large body of evidence support the use of potassium, L-arginine, vitamin C, cocoa flavonoids, coenzyme Q10, controlled-release melatonin, and aged garlic extract. However there is a need for data about the long-term safety of a large part of these products. Moreover, further clinical research is advisable to identify between the available active nutraceuticals and those with the best cost-effectiveness and risk-benefit ratio for widespread use in a general population with low added cardiovascular risk related to uncomplicated hypertension. PMID:23430658

Cicero, Arrigo F G; Borghi, Claudio

2013-06-01

24

C:\\Data\\My Documents\\NDA 21228 Peds web final final final ...  

Center for Drug Evaluation (CDER)

Text VersionPage 1. NDA 21-228 – SE-8 supplement 006 BPCA Clinical Review Drug: Detrol LA Capsules (tolterodine tartrate) 1.0 Brief Background: ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

25

A Change-Point Regression Approach for Efficacy Evaluation of Dietary Supplements  

PubMed Central

In clinical trials for dietary supplements and functional foods, the study population tends to be a mixture of healthy subjects and those who are not so healthy but are not definitely diseased (called “borderline subjects”). For such heterogeneous populations, the t-test and ANCOVA method often fail to provide the desired treatment efficacy. We propose an alternative approach for the efficacy evaluation of dietary supplements and functional foods based on a change-point linear regression model. The model does not require the assumption of a constant treatment effect and provides clinically interpretable results. By employing the AIC-based profile likelihood method, inferences can be made easily using standard statistical software. The proposed method was applied to the Garcinia study data, and the merit of the method was demonstrated by comparing it with traditional methods.

Hayamizu, Kohsuke; Yamashita, Natsumi; Hattori, Satoshi; Kakuma, Tatsuyuki

2009-01-01

26

Acute and sub acute toxicity and efficacy studies of Hippophae rhamnoides based herbal antioxidant supplement  

PubMed Central

Objectives: Present study was carried out to evaluate acute and subacute toxicity and efficacy of Seabuckthorn (Hippophae rhamnoides) based herbal antioxidant supplement (HAOS). Materials and Methods: In vivo toxicity studies were performed in male balb ‘C’ mice by oral administration. Acute toxicity study was done at doses ranging from 2000 to 10 000 mg/ kg while in subacute studies, HAOS was given at doses of 2000, 4000, and 8000 mg/kg body weight. Animals were observed for any toxic sign and symptoms periodically. At completion of study animals were sacrificed; their hematological, biochemical parameters were analyzed and histopathology of vital organs was done. In vivo efficacy studies in human volunteers were done and the levels of vitamin A and Vitamin C in blood samples were analyzed in comparison to a similar commercially available formulation. Results: No mortality and any clinical signs of toxicity were found in HAOS administered group of animals. There were no significant alterations in hematological and biochemical parameters. Histopathological analysis of vital organs showed normal architecture in all the HAOS administered groups. Human studies showed an increase of 32% and 172% in Vitamin A and Vitamin C levels respectively in term of bioavailability. Conclusion: The data obtained indicate no toxicity of this antioxidant supplement up to the highest dose studied. Efficacy in terms of increased bioavailability of vitamin A and C in human volunteers indicates the clinical usefulness of the supplement.

Ali, Rashid; Ali, Raisuddin; Jaimini, Abhinav; Nishad, Dhruv Kumar; Mittal, Gaurav; Chaurasia, Om Prakash; Kumar, Raj; Bhatnagar, Aseem; Singh, Shashi Bala

2012-01-01

27

Efficacy of dietary chromium (III) supplementation on tissue chromium deposition in finishing pigs.  

PubMed

The study was conducted to evaluate the efficacy of different forms of trivalent chromium (Cr) supplementation on tissue chromium deposition in finishing pigs. A total of 96 pigs with an initial average body mass 65.57±1.05 kg were blocked by body mass and randomly assigned to four treatments with three replicates. Pigs were offered one of four diets including a control diet or the control diet supplemented with 200 ?g/kg chromium from either chromium chloride (CrCl(3)), chromium picolinate (CrPic) or chromium nanocomposite (CrNano) for 40 days. During the trial, all pigs were given free access to feed and water. After feeding trial, eight pigs from each treatment were slaughtered for samples collection. The results showed that supplemental CrNano increased Cr content in blood, longissimus muscle, heart, liver, kidney, jejunum, and ileum (P<0.05). Supplemental Cr from three sources increased Cr excretion from all feces (P<0.05). Urinary Cr excretion was increased by CrNano or CrPic supplementation significantly. These results suggested that chromium nanocomposite exhibited more effective on tissue Cr deposition in pigs, which indicated higher absorption compared with CrCl(3) and CrPic. PMID:22383078

Wang, Min-Qi; Li, Hui; He, Yu-Dan; Wang, Chao; Tao, Wen-Jing; Du, Yong-Jie

2012-03-01

28

Dietary Supplement Use and Prostate Cancer Risk in the Carotene and Retinol Efficacy Trial  

PubMed Central

We investigated dietary supplement use and prostate cancer risk in the Carotene and Retinol Efficacy Trial (CARET). CARET was a randomized, double-blinded placebo-controlled trial testing a daily dose of 30 mg ?-carotene + 25,000 IU retinyl palmitate for lung cancer prevention (1985-1996; active follow-up occurred through 2005). Secondary outcomes, including prostate cancer, were also assessed. Participants were queried about dietary supplements, health history, family history of cancer, smoking and lifestyle habits. Cox proportional hazards regression estimated multivariate-adjusted relative risk (and 95% confidence intervals) of prostate cancer for dietary supplement users and non-users with or without the high-dose CARET vitamins during the intervention and post-intervention phases. After an average of 11 years of follow-up, 890 prostate cancer cases were reported. Neither the CARET nor other supplements were associated with total prostate cancer risk. For aggressive prostate cancer, men in the CARET intervention arm who used additional supplements had a relative risk for aggressive prostate cancer (Gleason ? 7 or stage III/IV) of 1.52 (95% CI, 1.03-2.24, p<0.05), relative to all others. These associations disappeared in the post-intervention period (0.75, 95%CI 0.51, 1.09). Conversely, there was no association of CARET + other supplements with non-aggressive disease, relative to all others. There was no effect modification by smoking or time on CARET intervention in any analyses. CARET only included smokers so findings reported here may not apply to non-smokers. Our results are consistent with other studies suggesting that dietary supplements may influence prostate cancer risk.

Neuhouser, Marian L; Barnett, Matt J; Kristal, Alan R.; Ambrosone, Christine B.; King, Irena B; Thornquist, Mark; Goodman, Gary G.

2009-01-01

29

Efficacy and safety of dietary supplements containing CLA for the treatment of obesity: evidence from animal and human studies  

Microsoft Academic Search

Dietary supplements containing conjugated linoleic acid (CLA) are widely promoted as weight loss agents avail- able over the counter and via the Internet. In this review, we evaluate the efficacy and safety of CLA supplementation based on peer-reviewed published results from random- ized, placebo-controlled, human intervention trials lasting more than 4 weeks. We also review findings from experi- mental studies

Thomas M. Larsen; Søren Toubro; Arne Astrup

2003-01-01

30

Fingolimod NDA 22 Fingolimod NDA 22-527  

Center for Biologics Evaluation and Research (CBER)

Text VersionPage 1. Fingolimod NDA 22 FDA Peripheral and CNS Advisory Committee Meet June 10, 2010 Novartis Pharmaceuticals Corpo Fingolimod ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

31

Application Type Supplemental NDA Application Number 201 ...  

Center for Drug Evaluation (CDER)

Text Version... Application Number 201-152/S-004 Submission Code SE-5 ... Another limitation of the NNRTIs is their relatively low genetic barrier to resistance. ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

32

NDA #20297 Supplement amendment: 022 dated September ...  

Center for Drug Evaluation (CDER)

Text Version... subjects included those with protocol defined medical conditions, were actively listed for transplantation or corrective heart surgery during the eight ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

33

Efficacy and safety of protein supplements for u.s. Armed forces personnel: consensus statement.  

PubMed

To provide evidence-based guidance regarding the efficacy and safety of dietary protein supplement (PS) use by members of the U.S. Armed Forces, a panel of internationally recognized experts in the fields of protein metabolism and dietary supplement research was convened by the Department of Defense Center Alliance for Dietary Supplement Research and the U.S. Army Medical Research and Material Command. To develop a consensus statement, potential benefits, risks, and strategies to optimize military performance through PS use were considered in the context of specific warfighter populations and occupational demands. To maintain muscle mass, strength, and performance during periods of substantial metabolic demand and concomitant negative energy balance the panel recommended that warfighters consume 1.5-2.0 g · kg(-1) · d(-1) of protein. However, if metabolic demand is low, such as in garrison, protein intake should equal the current Military Dietary Reference Intake (0.8-1.5 g · kg(-1) · d(-1)). Although PS use generally appears to be safe for healthy adults, warfighters should be educated on PS quality, given quality-control and contamination concerns with commercial dietary supplements. To achieve recommended protein intakes, the panel strongly urges consumption of high-quality protein-containing whole foods. However, when impractical, the use of PSs (20-25 g per serving or 0.25-0.3 g · kg(-1) per meal), particularly after periods of strenuous physical activity (e.g., military training, combat patrols, and exercise), is acceptable. The committee acknowledges the need for further study of protein requirements for extreme, military-specific environmental conditions and whether unique metabolic stressors associated with military service alter protein requirements for aging warfighters. PMID:24027189

Pasiakos, Stefan M; Austin, Krista G; Lieberman, Harris R; Askew, E Wayne

2013-09-11

34

Supplements  

Microsoft Academic Search

Dietary supplements are used either to increase the intake of dietary nutrients, such as vitamins, or to provide nutrients\\u000a that are not usually found in foods, e.g. in the form of herbal extracts. Supplements in the form of vitamin pills have been known for decades. Supplements of non-essential\\u000a nutrients are also widely available. The use of dietary supplements has become

Alan Mortensen

35

A preliminary study of the safety, feasibility and cognitive efficacy of soy isoflavone supplements in older men and women  

Microsoft Academic Search

Background: a small number of reports exist on the cognitive effects of soy isoflavones, the findings from which are mixed. Isoflavone efficacy is dependent upon conversion of glycosides contained in soy foods and supplements to the biologically active aglycons. Of particular interest is the production of the metabolite, equol, which is dependent upon intestinal microflora and an integrous digestive system,

CAREY E. GLEASON; C. M. Carlsson; J ODI H. BARNET; S ARAH A. MEADE; KENNETH D. R. SETCHELL; C RAIG S. ATWOOD; S TERLING C. JOHNSON; M ICHELE L. RIES; SANJAY ASTHANA

2008-01-01

36

Regulatory Options: NDA Process  

Center for Drug Evaluation (CDER)

Text Version... literature) ? It can rely upon our previous finding of safety and efficacy (ie, a previously approved product) ? Requires a scientific “bridge” to the ... More results from www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation

37

Confidence in the efficacy and safety of dietary supplements among United States active duty army personnel  

PubMed Central

Background United States Army Soldiers regularly use dietary supplements (DS) to promote general health, enhance muscle strength, and increase energy, but limited scientific evidence supports the use of many DS for these benefits. This study investigated factors associated with Soldiers’ confidence in the efficacy and safety of DS, and assessed Soldiers’ knowledge of federal DS regulatory requirements. Methods Between 2006 and 2007, 990 Soldiers were surveyed at 11 Army bases world-wide to assess their confidence in the effectiveness and safety of DS, knowledge of federal DS regulations, demographic characteristics, lifestyle-behaviors and DS use. Results A majority of Soldiers were at least somewhat confident that DS work as advertised (67%) and thought they are safe to consume (71%). Confidence in both attributes was higher among regular DS users than non-users. Among users, confidence in both attributes was positively associated with rank, self-rated diet quality and fitness level, education, and having never experienced an apparent DS-related adverse event. Fewer than half of Soldiers knew the government does not require manufacturers to demonstrate efficacy, and almost a third incorrectly believed there are effective pre-market federal safety requirements for DS. Conclusions Despite limited scientific evidence supporting the purported benefits and safety of many popular DS, most Soldiers were confident that DS are effective and safe. The positive associations between confidence and DS use should be considered when developing DS-related interventions or policies. Additionally, education to clarify Soldiers’ misperceptions about federal DS safety and efficacy regulations is warranted.

2012-01-01

38

CLINICAL TEAM LEADER REWIEW OF NDA EFFICACY ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... Progression-Free Survival N=451 N=438 All Patients 2.6 2.8 0.2 0.71 (0.62,0.82) p<0.0001 N=313 N=308 ... Overall Survival N=451 N=438 ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

39

The efficacy of lactic acid bacteria Pediococcus acidilactici, lactose and formic acid as dietary supplements for turkeys.  

PubMed

A feeding trial was performed on 1400 Big-6 turkey toms divided into experimental groups subject to the use of dietary supplements. The ain of this study was to evaluate the efficacy of the probiotic supplement Bactocell, containing lactic acid bacteria Pediococcus acidilactici, and lactose, administered to turkeys separately or in combination, as well as a formic acid supplement. The addition of the probiotic under test (lactic acid bacteria Pediococcus acidilactici) to diets for turkeys contributed to higher daily gains and lower feed consumption per kg weigh gain only during the first 12 weeks of their life. Diet supplementation with lactic acid bacteria and lactose reduced mortality rates. A slaughter value analysis revealed only a slightly (by approximately 1%) higher content of breast muscle and a lower content of thigh muscle in birds fed diets supplemented with lactic acid bacteria. Turkeys receiving lactic acid bacteria or lactose and a combination of both these supplements were characterized by a higher fat content of meat and slightly lower pH values, whereas meat from turkeys fed lactose-supplemented diets was darker in color. The addition of formic acid Acidum formicum to diets for turkeys contributed only to lower mortality rates. PMID:21077430

Wajda, S; Smieci?ska, K; Jankowski, J; Matusevicius, P; Buteikis, G

2010-01-01

40

Efficacy of dietary supplementation with botanicals on carbohydrate metabolism in humans.  

PubMed

Botanical products are widely used in nutritional supplementation for promotion of health or prevention of diseases. With the high prevalence of obesity and type 2 diabetes, abnormalities in carbohydrate metabolism are common in the general population and obtaining glycemic control is important in reducing the complications of diabetes. If shown to be effective, botanical products have a unique position in potentially aiding the general public in regard to obesity and diabetes. They can be obtained "over-the-counter" and may have less side effects compared to many synthetic drugs. Although most of the popular botanicals have a long history in folk medicine, there is paucity of data regarding their efficacy and safety, particularly as it relates to human studies. In this review, we discuss the data that was available in the literature for nine botanicals that are frequently promoted to help manage blood glucose. They are Bitter Melon (Momordica charantia), Fenugreek (trigonella foenum graecum), Gymnema Sylvestre, Ivy Gourd (Coccinia indica), Nopal or Prickly Pear Cactus (Opuntia streptacantha), Ginseng, Aloe Vera, Russian Tarragon (Artemisia dracunculus), and Garlic (Allium sativum). The discussion is emphasized on the clinical aspect of these botanicals. Due to the lack of sufficient evidence from clinical studies for any of the botanicals reviewed, it is premature to actively recommend use of any particular herb to treat either glucose or other risk factors. Thus, well defined randomized clinical trials are warranted in this area. PMID:18537692

Cefalu, William T; Ye, Jianping; Wang, Zhong Q

2008-06-01

41

NDA 20-972 NDA 21-360 IND 49, 465 REVISED WRITTEN ...  

Center for Drug Evaluation (CDER)

Text Version... NDA 20-972 NDA 21-360 IND 49, 465 REVISED WRITTEN REQUEST AMENDMENT #6 ... 3 months to < 6 months: 6 6 months to < 2 years: 6 ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

42

Nutritional supplement use by elite young UK athletes: fallacies of advice regarding efficacy  

Microsoft Academic Search

BACKGROUND: The objective was to study nutritional supplement use among young elite UK athletes to establish whether a rationale versus practice incongruence exists, and to investigate the sources of information. Survey data were analysed for association between supplements used and motives for using such substances among young athletes along with the sources of advice and literature precedents on supplement effects.

Andrea Petróczi; Declan P Naughton; Gemma Pearce; Richard Bailey; Andrew Bloodworth; Michael McNamee

2008-01-01

43

Review of the efficacy of green tea, isoflavones and aloe vera supplements based on randomised controlled trials.  

PubMed

We assess the evidence for health benefits of three commonly consumed plant food supplements (PFS), green tea, isoflavone and aloe vera, based on published systematic reviews of randomised controlled trials (RCTs). Whilst the potential benefits of green tea have been reported in a wide range of health areas, it is only in the area of the metabolic syndrome that the number of RCTs is approaching sufficient to judge such efficacy. Isoflavone supplements are widely used, and RCTs indicate that they affect bone resorption at lower doses in postmenopausal women undergoing estrogen-related bone loss, but this is only translated to attenuation of bone loss at higher doses of isoflavones. A systematic review on RCTs concluded that the effects of isoflavones on hot flashes in postmenopausal women were highly variable and no conclusions could be drawn. Despite the popularity of aloe vera as a PFS, the evaluation of its efficacy as a coadjuvant therapy for certain metabolic or digestive pathologies remains scarce; it constitutes a typical example of a naturally occurring ingredient whose efficacy in topical applications presupposes its efficacy in systemic applications. Nevertheless, its possible toxic effects on oral consumption call for caution in its utility as a PFS. Since 2007, efficacy evaluation of PFS in Europe has been covered by European Union Nutrition and Health Claims legislation. The European Food Safety Authority has adopted an approach relying on RCTs, while medicinal effects are accepted based on traditional use. In general, there are insufficient RCTs for claims to be made, and conclusive results on PFS should be obtained in the future by conducting studies with more homogeneous populations, by using supplements with optimised and measured bioavailability, and by conducting larger RCTs. PMID:21927741

Williamson, Gary; Coppens, Patrick; Serra-Majem, Lluís; Dew, Tristan

2011-09-19

44

Nutritional supplement use by elite young UK athletes: fallacies of advice regarding efficacy  

PubMed Central

Background The objective was to study nutritional supplement use among young elite UK athletes to establish whether a rationale versus practice incongruence exists, and to investigate the sources of information. Survey data were analysed for association between supplements used and motives for using such substances among young athletes along with the sources of advice and literature precedents on supplement effects. Methods Participants were elite UK male and female athletes, within the age range between 12 and 21 (n = 403), mean age 17.66 ± 1.99. Associations between type of supplements and reasons for using supplements were tested by calculating Pearson's ?2 and the strength of these symmetric associations shown by phi (?) association coefficients. Results Single supplement use was reported by 48.1%, with energy drinks being the most popular, consumed by 41.7% of all athletes and 86.6% of the supplement users in the sample. No agreement was observed between athletes' rationale and behaviour in relation to nutritional supplements except for creatine. Among health professionals, nutritionists and physiotherapists, followed by coaches, were most frequently consulted. Answers regarding reasons and supplements used showed incongruence and suggest widespread misinformation regarding supplements and their effects is an issue for the young athlete. Conclusion Widespread supplement taking behaviour was evidenced in the young elite athlete population with the most notable congruence between rationale and practice among young athletes being performance-related. Young athletes in the present sample appear to be less 'health conscious' and more 'performance focused' than their adult counterparts. Further research, using a full list of supplements, is warranted to test the hypothesis that health consciousness is less dominant in supplement choice by young athletes.

Petroczi, Andrea; Naughton, Declan P; Pearce, Gemma; Bailey, Richard; Bloodworth, Andrew; McNamee, Michael

2008-01-01

45

Creatine supplementation in health and disease: What is the evidence for long-term efficacy?  

Microsoft Academic Search

Creatine supplementation is an established ergogenic aid in sports and is now claimed to have therapeutical applications in a variety of diseases. The available literature mainly covers the short-term (one to several weeks) effects of creatine supplementation on skeletal muscle function in health and disease, which is of little help to evaluate the long-term (two or more months) potential of

Wim Derave; Bert O. Eijnde; Peter Hespel

2003-01-01

46

_____ _____ NDA  

Center for Drug Evaluation (CDER)

Text Version... Submission Dates: 27-March-2006, 06-June-2006, 07-July-2006 Primary Reviewer: Julie M. Bullock, Pharm.D. Pharmacometrics ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

47

Efficacy of combined iron and zinc supplementation on micronutrient status and growth in Vietnamese infants  

Microsoft Academic Search

Objective:To evaluate the effect of combined iron–zinc supplementation on micronutrient status, growth and morbidity.Design:Randomized, double-masked, placebo-controlled supplementation trial.Setting:Rural district of Que Vo, in the Red River Delta in Vietnam.Subjects:A total of 915 breast-fed infants aged 4–7 months were included and 784 completed the study.Interventions:The Fe-group received daily and for a 6-month period 10 mg of iron, the Zn-group 10 mg

J Berger; N X Ninh; N C Khan; N V Nhien; D K Lien; N Q Trung; H H Khoi

2006-01-01

48

Application Type NDA Submission Number 21168 ...  

Center for Drug Evaluation (CDER)

Text Version... Letter Date September 24, 2007 Stamp Date September 24, 2007 ... The following documents were reviewed during the NDA review process ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

49

FDA BRIEFING DOCUMENT NDA 202293 DAPAGLIFLOZIN ...  

Center for Biologics Evaluation and Research (CBER)

Text VersionPage 1. FDA BRIEFING DOCUMENT NDA 202293 DAPAGLIFLOZIN TABLETS, 5 AND 10 MG SPONSOR: BRISTOL-MYERS SQUIBB ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

50

FDA Briefing Document NDA 200063 Contrave (Naltrexone ...  

Center for Biologics Evaluation and Research (CBER)

Text VersionPage 1. FDA Briefing Document NDA 200063 Contrave (Naltrexone 4mg, 8mg/Bupropion HCL 90mg extended release tablet) ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

51

FDA Briefing Document NDA 22529 Lorqess (lorcaserin ...  

Center for Biologics Evaluation and Research (CBER)

Text VersionPage 1. FDA Briefing Document NDA 22529 Lorqess (lorcaserin hydrochloride) Tablets, 10 mg Sponsor: Arena Pharmaceuticals ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

52

The safety and efficacy of oral docosahexaenoic acid supplementation for the treatment of primary sclerosing cholangitis - a pilot study  

PubMed Central

SUMMARY Background Primary sclerosing cholangitis (PSC) is characterised by progressive inflammatory and fibrotic destruction of the biliary ducts. There are no effective medical therapies and presently high dose ursodeoxycholic acid is no longer recommended due to significant adverse events in a recent clinical trial. Cystic fibrosis transmembrane conductance regulator (CFTR) dysfunction is associated with PSC in both children and adults. Since CFTR dysfunction leads to altered fatty acid metabolism, specifically reduced docosahexaenoic acid (DHA), we hypothesised that DHA supplementation might be an effective therapy for patients with PSC. Aim To determine the safety and efficacy of oral DHA supplementation for the treatment of PSC. Methods We conducted a 12 month open-label pilot study to evaluate safety of oral DHA and its effects on serum alkaline phosphatase as a primary outcome measure in 23 patients with PSC. DHA was administered orally at 800 mg twice per day. Secondary outcomes included changes in other liver function tests and fibrosis biomarkers. Results A 1.7-fold increase in serum DHA levels was observed with supplementation. The mean alkaline phosphatase level (±S.E.) at baseline was 357.8 ± 37.1 IU compared to 297.1 ± 23.7 IU (P < 0.05) after 12 months of treatment. There were no changes in other liver function tests and fibrosis biomarkers. No adverse events were reported. Conclusions Oral DHA supplementation is associated with an increase in serum DHA levels and a significant decline in alkaline phosphatase levels in patients with PSC. These data support the need for a rigorous trial of DHA therapy in PSC.

Martin, C. R.; Blanco, P. G.; Keach, J. C.; Petz, J. L.; Zaman, M. M.; Bhaskar, K. R.; Cluette-Brown, J. E.; Gautam, S.; Sheth, S.; Afdhal, N. H.; Lindor, K. D.; Freedman, S. D.

2013-01-01

53

Efficacy of Parenteral Nutrition Supplemented With Glutamine Dipeptide to Decrease Hospital Infections in Critically Ill Surgical Patients  

PubMed Central

Background Nosocomial infections are an important cause of morbidity and mortality in the surgical intensive care unit (SICU). Clinical benefits of glutamine-supplemented parenteral nutrition may occur in hospitalized surgical patients, but efficacy data in different surgical subgroups are lacking. The objective was to determine whether glutamine-supplemented parenteral nutrition differentially affects nosocomial infection rates in selected subgroups of SICU patients. Methods This was a double-blind, randomized, controlled study of alanyl-glutamine dipeptide-supplemented parenteral nutrition in SICU patients requiring parenteral nutrition and SICU care after surgery for pancreatic necrosis, cardiac, vascular, or colonic surgery. Subjects (n = 59) received isocaloric/isonitrogenous parenteral nutrition, providing 1.5 g/kg/d standard glutamine-free amino acids (STD-PN) or 1.0 g/kg/d standard amino acids + 0.5 g/kg/d glutamine dipeptide (GLN-PN). Enteral feedings were advanced as tolerated. Nosocomial infections were determined until hospital discharge. Results Baseline clinical/metabolic data were similar between groups. Plasma glutamine concentrations were low in all groups and were increased by GLN-PN. GLN-PN did not alter infection rates after pancreatic necrosis surgery (17 STD-PN and 15 GLN-PN patients). In nonpancreatic surgery patients (12 STD-PN and 15 GLN-PN), GLN-PN was associated with significantly decreased total nosocomial infections (STD-PN 36 vs GLN-PN 13, P < .030), bloodstream infections (7 vs 0, P < .01), pneumonias (16 vs 6, P < .05), and infections attributed to Staphylococcus aureus (P < .01), fungi, and enteric Gram-negative bacteria (each P < .05). Conclusions Glutamine dipeptide-supplemented parenteral nutrition did not alter infection rates following pancreatic necrosis surgery but significantly decreased infections in SICU patients after cardiac, vascular, and colonic surgery.

Estivariz, Concepcion F.; Griffith, Daniel P.; Luo, Menghua; Szeszycki, Elaina E.; Bazargan, Niloofar; Dave, Nisha; Daignault, Nicole M.; Bergman, Glen F.; McNally, Therese; Battey, Cindy H.; Furr, Celeste E.; Hao, Li; Ramsay, James G.; Accardi, Carolyn R.; Cotsonis, George A.; Jones, Dean P.; Galloway, John R.; Ziegler, Thomas R.

2011-01-01

54

Efficacy of taurine supplementation for preventing green liver syndrome and improving growth performance in yearling red sea bream Pagrus major fed low-fishmeal diet  

Microsoft Academic Search

This study was performed to evaluate the efficacy of taurine supplementation for preventing green liver syndrome and improving\\u000a growth performance in red sea bream Pagrus major fed a low-fishmeal (FM) diet. Yearling red sea bream were fed for 34 weeks on low-FM diets either supplemented with taurine,\\u000a or without taurine, and the tissue taurine and bile pigment concentrations were measured.

Shusaku Takagi; Hisashi Murata; Takanobu Goto; Toshiaki Ichiki; Makoto Endo; Hideo Hatate; Terutoyo Yoshida; Tadashi Sakai; Hirofumi Yamashita; Masaharu Ukawa

2006-01-01

55

Efficacy of daily versus intermittent administration of iron supplementation in anemia or blood indices during pregnancy  

PubMed Central

Background: Pregnant women take iron supplements in order to prevent iron deficiency anemia which may have undesirable effects for both the mother and fetus. This study aimed to compare the daily and intermittent dose of iron supplementation in blood and iron indices in healthy pregnant women. Methods: In this clinical trial study, 145 healthy pregnant women were selected with Hb?11g%. The participants were randomly divided into two groups. Group 1 received daily iron supplement at 50 mg/day and group 2 received an intermittent dose of 3 times per week. Blood samples were assessed for complete blood count (Hb, Hct, RBC), iron, ferritin and zinc at baseline in the first trimester in all participants and the two groups were compared in regard to mean changes from baseline to the end of the study period in the third trimester. This clinical trial was registered in the Iranian Registry of Clinical Trials (www.irct.ir) with registration number ID: 2012082810682N1. Results: The incidence of iron deficiency anemia was 2.7% in both groups. The mean levels of Hb, Hct and RBC in the first trimester were 13.3 g/dl, 39.4% and 4.5 mil/ml3, respectively. At the end of the study, Hb, Hct, and RBC reduced significantly in both groups compared with baseline values (p<0.05). The difference from baseline in Hb and other blood indices did not differ significantly across the two groups. Conclusion: These findings indicate that daily or intermittent administration of iron supplement to pregnant women has the same outcome. Regarding the side effects of iron in pregnancy, intermittent method seems preferable to daily intake.

Sadighian, Farahnaz; Haydeh Samiei, Haydeh; Alaoddolehei, Haydeh; Kalantari, Narges

2013-01-01

56

Efficacy of acacia, pectin, and guar gum-based fiber supplementation in the control of hypercholesterolemia  

Microsoft Academic Search

We examined the lipid-lowering effects of an acacia, pectin, and guar gum-based product marketed as a fiber supplement, in 50 adults (mean age= 55.4 years) who had an LDL-C ? 4.1 mmol\\/l (160 mg\\/dl), or ? 3.4 mmol\\/l (130 mg\\/dl) if at least two coronary risk factors were present. All subjects were instructed on a Step I diet not to

Cindy Hosobuchi; Lapa Rutanassee; Stanley L. Bassin; Nathan D. Wong

1999-01-01

57

Plutonium NDA by thermal fluxmetry  

SciTech Connect

Quantitative nondestructive assay (NDA) measurements of calorific materials by calorimetry often encounter, in the case of samples with a volume {approx}1l or more, the difficulty of long measurement times. Nondestructive measurements at industrial production sites can sometimes be regarded as satisfactory, even with measurements that might carry a higher uncertainty, provided that the long measurement times can be significantly reduced. With this in mind, the authors have developed a spider-like thermal flux-meter for making quick nondestructive measurements of thermal powers up to 20 W for sample containers with a volume between 0.5 and 10l. The Fluxmeters developed are constructionally adapted to several different types of measurement features. The authors describe three types of fluxmeters that are suitable for rapid measurement times and have accuracies from 1 to a few percent for storage recesses or production facilities in the paper. Usually 5 to 8, and up to 25, fluxmeters are working simultaneously to reduce the mean measurement duration for a sample. The paper presents the results of an inventory control period involving the measurement of several hundred containers within 3 days by a three-man team.

Monier, J.; Sanson, C.; Bourrelly, P.; Patin, H.; Schoepp, R.

1987-01-01

58

Efficacy of Lactic Acid Bacteria (LAB) supplement in management of constipation among nursing home residents  

Microsoft Academic Search

BACKGROUND: Constipation is a significant problem in the elderly, specifically nursing home and\\/or extended-care facility residents are reported to suffer from constipation. Lactic acid bacteria (LAB) are beneficial probiotic organisms that contribute to improved nutrition, microbial balance, and immuno-enhancement of the intestinal tract, as well as diarrhea and constipation effect. The objective of this study was to investigate the efficacy

Hyang Mi An; Eun Hye Baek; Seok Jang; Do Kyung Lee; Mi Jin Kim; Jung Rae Kim; Kang Oh Lee; Jong Gi Park; Nam Joo Ha

2010-01-01

59

Efficacy of Supplemental Phonics-Based Instruction for Low-Skilled First Graders: How Language Minority Status and Pretest Characteristics Moderate Treatment Response  

ERIC Educational Resources Information Center

We examined the efficacy of 20 weeks of individual supplemental phonics-based instruction for language minority (LM) and non-LM first graders. Students were designated LM if the primary home language was not English (otherwise non-LM). Those performing in the bottom half of their classroom LM/non-LM group in letter knowledge and phonological…

Vadasy, Patricia F.; Sanders, Elizabeth A.

2011-01-01

60

Stat NDA Template Draft 2  

Center for Biologics Evaluation and Research (CBER)

Text Version... 1. Bleeding Episodes: In addition to the 4-point subjective VRS scale used in the studies by the Investigator or patients to determine clinical efficacy ... More results from www.fda.gov/downloads/biologicsbloodvaccines/bloodbloodproducts

61

Efficacy and safety of fortification and supplementation with vitamin B12: biochemical and physiological effects.  

PubMed

Long known as an uncommon but serious medical disorder requiring medical management, vitamin B12 deficiency is now seen to be common worldwide, but it is in a quite different form than traditionally envisioned. Most of the newly recognized deficiency is subclinical in nature, its health impact and natural history are uncertain, and its prevalence has been greatly inflated by also including persons with "low-normal" vitamin B12 levels, few of whom are deficient. The spread of folic acid fortification has also introduced concerns about folate's potentially adverse neurologic consequences in persons with undetected vitamin B12 deficiency. Fortification with vitamin B12 may prove more complicated than fortification with folic acid, however, because the bioavailability of vitamin B12 is limited. Bioavailability for those who need the vitamin B12 the most is especially poor, because they often have malabsorption affecting either classical intrinsic factor-mediated absorption or food-vitamin B12 absorption. Moreover, new evidence shows that many elderly persons respond poorly to daily oral doses under 500 microg (1 microg = 0.74 nmol), even if they do not have classical malabsorption, which suggests that proposed fortification with 1 to 10 microg may be ineffective. Those least in need of vitamin B12 usually have normal absorption and are thus at greatest risk for whatever unknown adverse effects of high-dose fortification might emerge, such as the effects of excess accumulation of cyanocobalamin. Studies are needed to define the still unproven health benefits of vitamin B12 fortification, the optimal levels of fortification, the stability of such fortification, interactions with other nutrients, and any possible adverse effects on healthy persons. The answers will permit formulation of appropriately informed decisions about mandatory fortification or (because fortification may prove a poor choice) about targeted supplementation in subpopulations with special needs for additional vitamin B12, such as vegetarians, nursing mothers, and the elderly. PMID:18709891

Carmel, Ralph

2008-06-01

62

A randomized controlled trial evaluating the efficacy and safety of vitamin E supplementation for protection against cisplatin-induced peripheral neuropathy: final results  

Microsoft Academic Search

Aim  A randomized, open label with blind assessment, controlled trial was performed to assess efficacy and adverse-event profile of vitamin E, given as supplementation for prophylaxis against cisplatin-induced peripheral neuropathy (CIPN).Patients and methods  A total of 30 patients scheduled to receive six courses of cumulative cisplatin-based regimens were randomly allocated to treatment and control groups and were then studied by means of

Andreas A. Argyriou; Elisabeth Chroni; Angelos Koutras; Gregoris Iconomou; Spiridon Papapetropoulos; Panagiotis Polychronopoulos; Haralabos P. Kalofonos

2006-01-01

63

NDA#19901 Supplement amendment: SE5-050 Sponsor ...  

Center for Drug Evaluation (CDER)

Text Version... The cognitive development assessment by parents/guardians and ... of ramipril use in children with hypertension ... clinician had treated a child less than ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

64

Efficacy of early neonatal vitamin A supplementation in reducing mortality during infancy in Ghana, India and Tanzania: study protocol for a randomized controlled trial  

PubMed Central

Background Vitamin A supplementation of 6-59 month old children is currently recommended by the World Health Organization based on evidence that it reduces mortality. There has been considerable interest in determining the benefits of neonatal vitamin A supplementation, but the results of existing trials are conflicting. A technical consultation convened by WHO pointed to the need for larger scale studies in Asia and Africa to inform global policy on the use of neonatal vitamin A supplementation. Three trials were therefore initiated in Ghana, India and Tanzania to determine if vitamin A supplementation (50,000 IU) given to neonates once orally on the day of birth or within the next two days will reduce mortality in the period from supplementation to 6 months of age compared to placebo. Methods/Design The trials are individually randomized, double masked, and placebo controlled. The required sample size is 40,200 in India and 32,000 each in Ghana and Tanzania. The study participants are neonates who fulfil age eligibility, whose families are likely to stay in the study area for the next 6 months, who are able to feed orally, and whose parent(s) provide informed written consent to participate in the study. Neonates randomized to the intervention group receive 50,000 IU vitamin A and the ones randomized to the control group receive placebo at the time of enrolment. Mortality and morbidity information are collected through periodic home visits by a study worker during infancy. The primary outcome of the study is mortality from supplementation to 6 months of age. The secondary outcome of the study is mortality from supplementation to 12 months of age. The three studies will be analysed independent of each other. Subgroup analysis will be carried out to determine the effect by birth weight, sex, and timing of DTP vaccine, socioeconomic groups and maternal large-dose vitamin A supplementation. Discussion The three ongoing studies are the largest studies evaluating the efficacy of vitamin A supplementation to neonates. Policy formulation will be based on the results of efficacy of the intervention from the ongoing randomized controlled trials combined with results of previous studies. Trial Registration Ghana: Australian New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12610000582055; India: CLINICALTRIALS.GOV - NCT01138449; Tanzania: Australian New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12610000636055.

2012-01-01

65

Methods and techniques of NDA (nondestructive assay)  

SciTech Connect

Nondestructive assay (NDA) refers to techniques and instruments developed to measure nuclear materials in the many forms in which they occur throughout the fuel cycle. These techniques were first developed to support nuclear safeguards inspections and nuclear material accountability; they are also used extensively for process and quality control. Most accountability measurements are based on analytical chemistry and require that a sample be drawn and analyzed destructively. Destructive analysis can not be applied to many of the product materials found in the fuel cycle, such as fuel rods and assemblies, because of their high monetary value. Also, many waste and scrap materials can not be adequately sampled for destructive analysis because of their heterogenous nature. This situation led to the development of nondestructive analysis techniques. This paper presents an overview of the major NDA techniques and instrumentation in use today. The instrumentation described below is now used frequently by safeguards inspectors and facility operators alike. 19 refs., 18 figs., 4 tabs.

Reilly, T.D.

1988-01-01

66

Los Alamos safeguards program overview and NDA in safeguards  

SciTech Connect

Over the years the Los Alamos safeguards program has developed, tested, and implemented a broad range of passive and active nondestructive analysis (NDA) instruments (based on gamma and x-ray detection and neutron counting) that are now widely employed in safeguarding nuclear materials of all forms. Here very briefly, the major categories of gamma ray and neutron based NDA techniques, give some representative examples of NDA instruments currently in use, and cite a few notable instances of state-of-the-art NDA technique development. Historical aspects and a broad overview of the safeguards program are also presented.

Keepin, G.R.

1988-01-01

67

2003 Biological New Drug Application (NDA) and Abbreviated ...  

Center for Biologics Evaluation and Research (CBER)

... Tradename/ Established Name, Indication for Use, NDA Number, Applicant, Approval Date. triCitrasol Anticoagulant Sodium Citrate Conc. ... More results from www.fda.gov/biologicsbloodvaccines/developmentapprovalprocess/biologicalapprovalsbyyear

68

2005 Biological New Drug Application (NDA) and Abbreviated ...  

Center for Biologics Evaluation and Research (CBER)

... 2005 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals. This list reflects ... More results from www.fda.gov/biologicsbloodvaccines/developmentapprovalprocess/biologicalapprovalsbyyear

69

2009 Biological New Drug Application (NDA) and Abbreviated ...  

Center for Biologics Evaluation and Research (CBER)

... 2009 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals. This list reflects ... More results from www.fda.gov/biologicsbloodvaccines/developmentapprovalprocess/biologicalapprovalsbyyear

70

NDA 080041, Amendment 011 - Review of March 18, 2009 ...  

Center for Biologics Evaluation and Research (CBER)

... NDA 080041, Amendment 011 - Review of March 18, 2009 Response to Information on Stability Testing - Intersol. United ... More results from www.fda.gov/biologicsbloodvaccines/bloodbloodproducts/approvedproducts

71

2012 Biological New Drug Application (NDA) and Abbreviated ...  

Center for Biologics Evaluation and Research (CBER)

... 1996 Biological Approvals. -. 2012 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals. ... More results from www.fda.gov/biologicsbloodvaccines/developmentapprovalprocess/biologicalapprovalsbyyear

72

M:\\Data\\My Documents\\Sara\\NDA 20732\\letters ...  

Center for Drug Evaluation (CDER)

Text Version... Page 4. NDA 20-732 NDA 20-733 Page 28 • Put the tablets under your tongue and let them melt. This will take 2 to 10 minutes. ... More results from www.fda.gov/downloads/drugs/drugsafety

73

FDA Clinical Review of Efficacy and Safety NDA 22529 ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... Valvular Heart Disease – Depression- and Suicide-Related Events ... Aminorex: associated with an “epidemic” of PPH in Europe in the 1960s ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

74

The efficacy of calcium supplementation alone in elderly Thai women over a 2-year period: a randomized controlled trial.  

PubMed

Supplementation with elemental calcium 500 mg/day alone for 2 years is able to decrease bone turnover and is effective in retarding bone loss at lumbar spine and slowing bone loss at femoral neck in elderly Thai women who had low dietary calcium intake. INTRODUCTION: Most elderly Thais have a total dietary calcium intake of less than the recommended amount. The aim of the study was to investigate the effect of calcium supplementation on bone mineral density and biochemical indices of bone remodeling in Thai postmenopausal women. METHODS: Four hundred and four healthy postmenopausal women 60 years old or older without osteoporosis were recruited and conducted in a randomized, double-blinded, placebo-controlled trial. They were randomly given elementary calcium 500 mg/day or placebo for 2 years. Dietary calcium intake was calculated from the nutrient compositional analysis of the 3-day food records. Serum 25 hydroxyvitamin D was measured by radioimmunoassay and bone turnover markers were determined by electrochemiluminescence immunoassay. RESULTS: The age of the subjects was 65.8?±?4.4 years. All baseline characteristics of the subjects in the calcium-supplemented group and the placebo group were not statistically different. At the end of the study, significant decreases in serum C-terminal telopeptide of type I collagen and serum total procollagen type I amino terminal propeptide in the calcium-supplemented group were observed, while there was no change in the placebo group. In addition, plasma parathyroid hormone decreased, although not significantly, only in the calcium-supplemented group. Percent changes from baseline of lumbar spine (L2-L4) bone mineral density increased 2.76 % in the calcium-supplemented group and 0.87 % in the placebo group, whereas the percent changes from baseline of femoral neck decreased 0.21 % in the calcium-supplemented group and 0.90 % in the placebo group. CONCLUSIONS: Calcium supplementation is necessary for the decrease of bone turnover and prevention of bone loss in Thai elderly women. PMID:23681085

Rajatanavin, R; Chailurkit, L; Saetung, S; Thakkinstian, A; Nimitphong, H

2013-05-17

75

FDA Briefing Document Advisory Committee Meeting for NDA ...  

Center for Biologics Evaluation and Research (CBER)

Text VersionPage 1. FDA Briefing Document Advisory Committee Meeting for NDA 21071 Avandia (rosiglitazone maleate) tablet July 13 and 14, 2010 Page 2. ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

76

NDA accountability measurement needs in the DOE plutonium community  

SciTech Connect

The purpose of this first ATEX report is to identify the twenty most vital nondestructive assay (NDA) accountability measurement needs in the DOE plutonium community to DOE and to contractor safeguards RandD managers in order to promote resolution of these needs. During 1987, ATEX identified sixty NDA accountability measurement problems, many of which were common to each of the DOE sites considered. These sixty problems were combined into twenty NDA accountability measurement needs that exist within five major areas: NDA ''standards'' representing various nuclear materials and matrix composition; Impure nuclear materials compounds, residues, and wastes; Product-grade nuclear materials; Nuclear materials process holdup and in-process inventory; and Nuclear materials item control and verification. 2 figs.

Ostenak, C.A.

1988-08-31

77

The committee will discuss new drug application (NDA) 22407 ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... The committee will discuss new drug application (NDA) 22407, telavancin sterile powder for injection, application submitted by Theravance ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

78

Efficacy of Chromium(III) Supplementation on Growth, Body Composition, Serum Parameters, and Tissue Chromium in Rats  

Microsoft Academic Search

Chromium(III) is often claimed to have a positive effect on body composition, while the responses in researches with supplementation\\u000a of different chemical form of chromium are various and inconsistent. We have studied the effects of 6 weeks of treatment with\\u000a three different forms of chromium (300 ?g\\/kg) as chromium chloride, chromium tripicolinate, and chromium nanocomposite (CrNano)\\u000a on growth, body composition, serum parameters,

L. Y. Zha; M. Q. Wang; Z. R. Xu; L. Y. Gu

2007-01-01

79

Haptoglobin phenotype, preeclampsia risk and the efficacy of vitamin C and E supplementation to prevent preeclampsia in a racially diverse population.  

PubMed

Haptoglobin's (Hp) antioxidant and pro-angiogenic properties differ between the 1-1, 2-1, and 2-2 phenotypes. Hp phenotype affects cardiovascular disease risk and treatment response to antioxidant vitamins in some non-pregnant populations. We previously demonstrated that preeclampsia risk was doubled in white Hp 2-1 women, compared to Hp 1-1 women. Our objectives were to determine whether we could reproduce this finding in a larger cohort, and to determine whether Hp phenotype influences lack of efficacy of antioxidant vitamins in preventing preeclampsia and serious complications of pregnancy-associated hypertension (PAH). This is a secondary analysis of a randomized controlled trial in which 10,154 low-risk women received daily vitamin C and E, or placebo, from 9-16 weeks gestation until delivery. Hp phenotype was determined in the study prediction cohort (n = 2,393) and a case-control cohort (703 cases, 1,406 controls). The primary outcome was severe PAH, or mild or severe PAH with elevated liver enzymes, elevated serum creatinine, thrombocytopenia, eclampsia, fetal growth restriction, medically indicated preterm birth or perinatal death. Preeclampsia was a secondary outcome. Odds ratios were estimated by logistic regression. Sampling weights were used to reduce bias from an overrepresentation of women with preeclampsia or the primary outcome. There was no relationship between Hp phenotype and the primary outcome or preeclampsia in Hispanic, white/other or black women. Vitamin supplementation did not reduce the risk of the primary outcome or preeclampsia in women of any phenotype. Supplementation increased preeclampsia risk (odds ratio 3.30; 95% confidence interval 1.61-6.82, p<0.01) in Hispanic Hp 2-2 women. Hp phenotype does not influence preeclampsia risk, or identify a subset of women who may benefit from vitamin C and E supplementation to prevent preeclampsia. PMID:23573260

Weissgerber, Tracey L; Gandley, Robin E; McGee, Paula L; Spong, Catherine Y; Myatt, Leslie; Leveno, Kenneth J; Thorp, John M; Mercer, Brian M; Peaceman, Alan M; Ramin, Susan M; Carpenter, Marshall W; Samuels, Philip; Sciscione, Anthony; Harper, Margaret; Tolosa, Jorge E; Saade, George; Sorokin, Yoram

2013-04-03

80

Multivitamin supplementation in HIV infected adults initiating antiretroviral therapy in Uganda: the protocol for a randomized double blinded placebo controlled efficacy trial  

PubMed Central

Background Use of multivitamin supplements during the pre-HAART era has been found to reduce viral load, enhance immune response, and generally improve clinical outcomes among HIV-infected adults. However, immune reconstitution is incomplete and significant mortality and opportunistic infections occur in spite of HAART. There is insufficient research information on whether multivitamin supplementation may be beneficial as adjunct therapy for HIV-infected individuals taking HAART. We propose to evaluate the efficacy of a single recommended daily allowance (RDA) of micronutrients (including vitamins B-complex, C, and E) in slowing disease progression among HIV-infected adults receiving HAART in Uganda. Methods/Design We are using a randomized, double-blind, placebo-controlled trial study design. Eligible patients are HIV-positive adults aged at least 18 years, and are randomized to receive either a placebo; or multivitamins that include a single RDA of the following vitamins: 1.4 mg B1, 1.4 mg B2, 1.9 mg B6, 2.6 mcg B12, 18 mg niacin, 70 mg C, 10 mg E, and 0.4 mg folic acid. Participants are followed for up to 18 months with evaluations at baseline, 6, 12 and 18 months. The study is primarily powered to examine the effects on immune reconstitution, weight gain, and quality of life. In addition, we will examine the effects on other secondary outcomes including the risks of development of new or recurrent disease progression event, including all-cause mortality; ARV regimen change from first- to second-line therapy; and other adverse events as indicated by incident peripheral neuropathy, severe anemia, or diarrhea. Discussions The conduct of this trial provides an opportunity to evaluate the potential benefits of this affordable adjunct therapy (multivitamin supplementation) among HIV-infected adults receiving HAART in a developing country setting. Trial registration Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01228578

2012-01-01

81

NDA SYSTEM RESPONSE MODELING AND ITS APPLICATION  

SciTech Connect

The Portsmouth gaseous diffusion plant (PORTS) is a uranium enrichment facility that was historically used to enrich uranium to levels that range from 2% to greater than 97%. The feed material for PORTS was obtained from the Paducah Gaseous Diffusion Plant (PGDP) that produced uranium in the form of UF6 that was enriched to about 1 to 2%. The enrichment process involves a multistage process by which gaseous UF{sub 6} passed through a diffusion barrier in each stage. The porous diffusion barrier in each stage retards the rate of the diffusion of the heavier {sup 238}U atoms relative to the diffusion of the lighter {sup 235}U atoms. By this process the product stream is slightly enriched by each stage of the process. Each stage consists of a compressor, converter and a motor. There are more than 4000 stages that are linked together with piping of various diameters to form the PORTS cascade. The cascade spans three interconnected buildings and comprises miles of piping, thousands of seals, converters, valves, motors, and compressors. During operation, PORTS process equipment contained UF{sub 6} gas with uranium enrichment that increased in the process stream from the first to the last stage in a known manner. Gaseous UF{sub 6} moving through the PORTS process equipment had potential to form deposits within the process equipment by several mechanisms, including solidification due to incorrect temperature and pressure conditions during the process, inleakage of atmospheric moisture that chemically reacts with UF{sub 6} to form hydrated uranyl fluoride solids, reduction reactions of UF{sub 6} with cascade metals, and UF{sub 6} condensation on the internal equipment surfaces. As a result, the process equipment of the PORTS contains a variable and unknown quantity of uranium with variable enrichment that has been deposited within the equipment during plant operations. The exact chemical form of this uranium is variable, although it is expected that the bulk of the material is of the form of uranyl fluoride that will become hydrated on exposure to moisture in air when the systems are no longer buffered. The deposit geometry and thickness is uncertain and variable. However, a reasonable assessment of the level of material holdup in this equipment is necessary to support decommissioning efforts. The assessment of nuclear material holdup in process equipment is a complex process that requires integration of process knowledge, nondestructive assay (NDA) measurements, and computer modeling to maximize capabilities and minimize uncertainty. The current report is focused on the use of computer modeling and simulation of NDA measurements.

Vinson, D.

2010-03-01

82

?-Alanine supplementation.  

PubMed

?-Alanine is rapidly developing as one of the most popular sport supplements used by strength/power athletes worldwide. The popularity of ?-alanine stems from its unique ability to enhance intramuscular buffering capacity and thereby attenuating fatigue. This review will provide an overview of the physiology that underlies the mechanisms of action behind ?-alanine, examine dosing schemes, and examine the studies that have been conducted on the efficacy of this supplement. In addition, the effect that ?-alanine has on body mass changes or whether it can stimulate changes in aerobic capacity also will be discussed. The review also will begin to explore the potential health benefits that ?-alanine may have on older adult populations. Discussion will examine the potential adverse effects associated with this supplement as well as the added benefits of combining ?-alanine with creatine. PMID:22777329

Hoffman, Jay R; Emerson, Nadia S; Stout, Jeffrey R

83

Preliminary Assessment of the Efficacy of Supplementing Knee Extension Capability in a Lower Limb Exoskeleton with FES  

PubMed Central

The authors describe a cooperative controller that combines the knee joint actuation of an externally powered lower limb exoskeleton with the torque and power contribution from the electrically stimulated quadriceps muscle group. The efficacy of combining these efforts is experimentally validated with a series of weighted leg lift maneuvers. Measurements from these experiments indicate that the control approach effectively combines the respective efforts of the motor and muscle, such that good control performance is achieved, with substantial torque and energy contributions from both the biological and non-biological actuators.

Quintero, Hugo A.; Farris, Ryan J.; Ha, Kevin; Goldfarb, Michael

2013-01-01

84

The efficacy of Irvingia gabonensis supplementation in the management of overweight and obesity: a systematic review of randomized controlled trials.  

PubMed

The aim of this systematic review was to evaluate the evidence from randomized controlled trials (RCTs) involving the use of the African Bush Mango, Irvingia gabonensis for body weight reduction in obese and overweight individuals. Electronic and nonelectronic searches were conducted to identify relevant RCTs. The bibliographies of located articles were also searched. No age, gender, or language restrictions were imposed. The reporting quality of identified RCTs was assessed using a methodological checklist adapted from the Consolidated Standard of Reporting Trials Statement and Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Two reviewers independently determined eligibility and assessed the reporting quality of included studies. Three RCTs were identified, and all were included. The RCTs all had flaws in the reporting of their methodology. All RCTs reported statistically significant reductions in body weight and waist circumference favoring I. gabonensis over placebo. The results from the RCTs also suggest positive effects of I. gabonensis supplementation on the blood lipid profile. Adverse events included headache and sleep difficulty. Due to the paucity and poor reporting quality of the RCTs, the effect of I. gabonensis on body weight and related parameters are unproven. Therefore, I. gabonensis cannot be recommended as a weight loss aid. Future research in this area should be more rigorous and better reported. PMID:23419021

Onakpoya, Igho; Davies, Lucy; Posadzki, Paul; Ernst, Edzard

2013-03-01

85

Efficacy and safety of insulin lispro protamine suspension as basal supplementation in patients with type 2 diabetes  

PubMed Central

The three currently marketed long-acting insulin analogs, glargine, detemir and insulin lispro protamine suspension (ILPS), represent the most significant advances in basal insulin supplementation since the 1940s and 1950s and the introduction of the intermediate-acting NPH (neutral protamine Hagedorn) insulin. As injection of NPH insulin lacks chronic maintenance of a steady-state low-level basal insulin during fasting periods, which can also expose patients to unpredictable nocturnal hypoglycemia, long-acting insulin analogs have been developed to overcome this important limitation of NPH insulin. ILPS is a protamine-based, intermediate-acting insulin formulation of the short-acting analog insulin lispro: its pharmacokinetic and pharmacodynamic characteristics are quite similar to the other basal insulin analogs glargine and detemir. In recent head-to-head randomized controlled trials of insulin-naïve patients with type 2 diabetes, ILPS achieved similar glycemic control compared with glargine or detemir. ILPS administered once daily is an effective and safe way to maintain a steady-state low-level basal insulin during night time, not dissimilar from that currently obtained with a one-day glargine or detemir administration.

Esposito, Katherine

2012-01-01

86

Dietary supplements for football  

Microsoft Academic Search

Physical training and competition in football markedly increase the need for macro- and micronutrient intake. This requirement can generally be met by dietary management without the need for dietary supplemens. In fact, the efficacy of most supplements available on the market is unproven. In addition, players must be cautious of inadequate product labelling and supplement impurities that may cause a

P. Hespel; R. J. Maughan; P. L. Greenhaff

2006-01-01

87

Clinical efficacy and cost comparison of an amiloride-hydrochlorothiazide combination versus hydrochlorothiazide and wax-matrix potassium supplement in the treatment of essential hypertension.  

PubMed

To compare the clinical efficacy and cost of therapy with an amiloride-hydrochlorothiazide combination versus hydrochlorothiazide and a wax-matrix potassium supplement, we reviewed the medical records of 20 hypertensive men who had received both treatments. The review period included 5.9 +/- 0.9 (mean +/- SE) months on hydrochlorothiazide and wax-matrix potassium and 5.3 +/- 0.7 months after changeover to the amiloride-hydrochlorothiazide combination. Control of blood pressure, maintenance of serum potassium levels, and number of outpatient visits were similar before and after the change in therapy. The monthly cost of medication, based on the lowest listed price in the Drug Topics Red Book and also in the Red Book Update, was approximately 12% higher for the hydrochlorothiazide and wax-matrix potassium regimen than for the amiloride-hydrochlorothiazide combination, whereas the federal agency contract price for the latter was significantly higher. The change to the amiloride-hydrochlorothiazide combination reduced the mean number of tablets taken daily from 5.3 +/- 0.6 to 1.25 +/- 0.1, suggesting a more convenient therapeutic regimen. PMID:3731211

Vardan, S; Rapacke, J; Mookherjee, S

1986-01-01

88

Considerations for NDA in Waste and D and D Applications  

SciTech Connect

Non Destructive Assay (NDA) is a common tool for waste characterization, decontamination and decommissioning (D and D) applications. However there are many things which must be considered in order to set up and run an efficient, cost effective, and successful NDA program for these applications. This paper covers some of these issues and points out examples of how they can affect the programmatic decisions. Most NDA programs were established initially based on measurements performed in a fixed geometry in a laboratory or process work environment. When the process is moved into the rugged environment of the D and D world, issues such as temperature variations, significant changes in background radiation levels, difficulties in operating the equipment when working in personal protective equipment (PPE), difficulties in setting up equipment in appropriate locations for performing measurements, all contribute to the possibility of additional measurement uncertainties or significant measurement errors which may not have been initially considered. For this reason, a good NDA program should have a strong technical lead, who is out in the field performing walk downs of the area and items to be measured, evaluating the problems which the operators are experiencing in performing field measurements, and writing easy to use measurement plans for upcoming measurements.

Gillespie, Bruce [Canberra Industries 2425 Stevens Center Drive, Richland WA 99352 (United States)

2008-01-15

89

[A randomized, double-blind, placebo-controlled study of the antilipemic efficacy and tolerability of food supplement policosanol in patients with moderate hypercholesterolemia].  

PubMed

This randomized, double-blind, placebo-controlled crossover study was performed in 67 patients of both sexes aged 20 to 78 years with moderate hypercholesterolemia to investigate the antilipemic efficacy and tolerability of food supplement policosanol--a mixture of aliphatic primary alcohols from rice (Oryza sp.). After a 8-week run-in period in which patients were placed on therapeutic lifestyle changes, in particular cholesterol-lowering diet, they were randomly assigned to receive policosanol 10 mg capsules or placebo capsules once daily with the evening meal for 8 weeks. During next 8 weeks those receiving policosanol during the first 8 weeks, received placebo and those taking placebo during the first 8 weeks, received policosanol. Total cholesterol (C), LDL-C, HDL-C, HDL2-C, HDL3-C, triglycerides, oxidized LDL, apoproteins A I and B and lipoprotein (a) as well as AST, ALT, GGT, CK, blood glucose and bilirubin were determined before the treatment, after the first part of the study i.e. after the first 8 weeks and at the end of the study, i.e after the second 8 weeks. Policosanol significantly reduced plasma total cholesterol and increased apoprotein A I but did not change plasma triglycerides, HDL-C, HDL2-C, HDL3-C, LDL-C, oxidized LDL, Lp (a) and apoproteinS. It was well tolerated, with no drug-related effects on safety parameters such as serum aminotransferases, blood glucose, bilirubin, and CK, neither did it cause any clinical adverse reactions. PMID:16583932

Tedeschi-Reiner, Eugenia; Reiner, Zeljko; Romi?, Zeljko; Ivankovi?, Davor

90

Efficacy Supplement Approvals in 1998  

Center for Drug Evaluation (CDER)

... CEFPODOXIME PROXETIL, PHARMACIA AND UPJOHN, 50-675, 22-Dec-97, 20-Nov-98, SE2, 10.9, 5-day treatment of otitis media in pediatric ... More results from www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved

91

Efficacy Supplement Approvals in 2007  

Center for Drug Evaluation (CDER)

... for intravenous administration in a controlled clinical setting for the ... paclitaxel protein-bound particles, Abraxis BioScience, 021660, SE8, 010, 04/18/06 ... More results from www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved

92

Efficacy Supplement Approvals in 1999  

Center for Drug Evaluation (CDER)

... PHARMACIA AND UPJOHN, 20-287, 06/01/98, 05/25/99, SE1, 10, N, 11.8, Treatment of unstable angina and non-Q-wave myocardial infarction and ... More results from www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved

93

Efficacy Supplement Approvals in 2005  

Center for Drug Evaluation (CDER)

... for Ortho TriCyclen to incorporate the results from the CAPPS-169 study entitled “The Effect of Ortho TriCyclen on Bone Mineral Density in Pediatric ... More results from www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved

94

Efficacy Supplement Approvals in 2004  

Center for Drug Evaluation (CDER)

... to the CLINICAL PHARMACOLOGY, CLINICAL STUDIES and ADVERSE ... description of a clinical study of Ultiva vs ... for the use of Adderall XR in the ... More results from www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved

95

Efficacy Supplement Approvals in 2000  

Center for Drug Evaluation (CDER)

... GABAPENTIN, PARKE DAVIS PHARMS, 20-235, 15-Dec-99, 12-Oct-00, SE1, 015, N, 9.9, Provides for the use of Neurontin as adjunctive therapy in ... More results from www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved

96

Efficacy Supplement Approvals in 2001  

Center for Drug Evaluation (CDER)

... the use of Zithromax (azithromycin) for Oral Suspension for acute otitis media with a 3 ... sodium nasal solution) nasal spray for use in children down to ... More results from www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved

97

A brief history of NDA at the IAEA.  

SciTech Connect

Nearly 30 years ago, the first portable nondestructive assay instrument, a SAM-II, was brought to Vienna for IAEA consideration. This initial foray into the usage of nondestructive assay (NDA) as an independent assessment tool has materialized into one of the important tools for IAEA inspections. NDA instruments have several inherent advantages for inspectors; their measurements generate no radioactive waste, provide immediate answers, do not require specialized operators, and can be either taken to the items to be measured (portable instruments), or the items for measurement can be brought to the instruments, such as can be applied in on-site IAEA laboratories or off-site IAEA lab at Siebersdorf. The SAM-II was a small, lightweight, battery-powered, gamma-ray instrument used for uranium enrichment measurements. It was also found to be usehl for locating nuclear material, distinguishing between uranium and plutonium, and determining the active length of items like fuel pins. However it was not well suited for determining the amount of bulk material present, except for small containers of low-density materials. A 6-sided neutron coincidence counter, easily disassembled so it could be shipped and carried by airplane, was developed for bulk measurements of plutonium. The HLNCC (High Level Neutron Coincidence Counter) was immediately useful for quantitative measurements of pure plutonium oxide. However, the IAEA had to make a trade-off between the ease of use of NDA instruments on-site, and the problems of obtaining small samples for shipment to an independent lab for more accurate analysis. NDA does not create radioactive waste, so as waste handling has become more cautious and more regulated, NDA looks better and better. After acceptance of NDA by the IAEA for routine use, the follow-up question was naturally, 'How much better can this measurement be made?' The Program for Technical Assistance to IAEA Safeguards (POTAS) supported multiple and varied efforts in this direction, such as improving both the plutonium isotopic distribution measurement and the multiplicity counter, so that the assays can be performed on any plutonium samples instead of only pure oxides. Advances have also been made on uranium bulk measurements by the development of the active well coincidence counter. Meanwhile, several large bulk-handling facilities have been coming on line under IAEA safeguards. These facilities require full-time inspectors to be present whenever the plant is operating. The IAEA requested help so that measurements can be made even when inspectors are not present. The evolution and success of unattended NDA has been responsible for the capability of the IAEA to monitor large bulk-handling facilities without substantial increase in inspection effort. The integration of NDA with containment & surveillance measures and automation has been crucial to reducing inspection manpower. These systems have developed to the point where the IAEA can make credible conclusions on large high-throughput plants such as mixed-oxide (MOX) fuel fabrication or reprocessing plants.

Sprinkle, J. K. (James K.); Sinkule, B. J. (Barbara J.); Hsue, S.-T. (Sin-Tao); Abhold, M. E. (Mark E.)

2001-01-01

98

A neutron method for NDA analysis in the SAPPHIRE Project  

SciTech Connect

The implementation of Project SAPPHIRE, the top secret mission to the Republic of Kazakhstan to recover weapons grade nuclear materials, consisted of four major elements: (1) the re-packing of fissile material from Kazakh containers into suitable US containers; (2) nondestructive analyses (NDA) to quantify the U-235 content of each container for Nuclear Criticality Safety and compliance purposes; (3) the packaging of the fissile material containers into 6M/2R drums, which are internationally approved for shipping fissile material; and (4) the shipping or transport of the recovered fissile material to the United States. This paper discusses the development and application of a passive neutron counting technique used in the NDA phase of SAPPHIRE operations to analyze uranium/beryllium (U/Be) alloys and compounds for U-235 content.

Lewis, K.D.

1995-01-09

99

Supplements and athletes.  

PubMed

Supplements have become a staple with athletes. Athletes take supplements to enhance their performance through replenishment of real and perceived deficiencies, anabolic action of stimulants, increased energy and alertness, and for weight control. Physicians who deal with athletes should be aware of the supplements being utilized by athletes, the athletes' desired effects and the efficacy of the supplement, the adverse effects, and whether the supplement is banned by leagues or organizations in which the athletes are competing. For those athletes who are regularly drug tested for performance enhancers, it is important to remember that one cannot be 100% sure that any supplement will not result in a positive drug test, because there is no independent agency certifying purity. PMID:15455977

Lombardo, John A

2004-09-01

100

NDA SNR estimation for 32APSK in AWGN  

Microsoft Academic Search

32-amplitude and phase-shift-keying (32APSK) is one of the modulation schemes proposed in the 2nd generation digital video broadcasting over satellite (DVB-S2) standard. This paper presents a non-data-aided (NDA) SNR estimation scheme for 32APSK using the expectation-maximization (EM) algorithm. Two variants of the EM algorithm are presented, first with an arbitrary initialization and a second version that is initialized by modifying

A. Das; J. Ng

2008-01-01

101

The efficacy of bait supplements for improving the rate of discovery of bait stations in the field by the formosan subterranean termite (Isoptera: Rhinotermitidae)  

Technology Transfer Automated Retrieval System (TEKTRAN)

Field tests of four different bait supplements were conducted in City Park, New Orleans, Louisiana. The four bait supplements tested included two different formulations of decayed material, a sports drink, and the combination of an application of an aqueous solution of Summon Preferred Food SourceTM...

102

Characterization of waste drums using nonintrusive NDE/NDA methods  

SciTech Connect

Characterization of mixed (radioactive and hazardous) wastes requires that all hazardous (e.g., heavy metals, volatile organic compounds-VOCs-and non-VOCs) and non-conforming materials (e.g. free liquids and pressurized containers) be identified, and that the identity and strengths of intrinsic radioactive sources be determined accurately. Comprehensive and accurate nondestructive evaluation (NDE) and nondestructive assay (NDA) methods can be used in this identification and determination process. With accurate quantitative data, wastes would be properly characterized and then discarded in the safest and most cost-effective manner without any need to open the waste container.

Martz, H.E.; Roberson, G.P.; Azevedo, S.G.; Ryon, R.W.

1993-12-01

103

Session 31B - Panel: Opportunities in the UK with the Nuclear Decommissioning Authority (NDA)  

SciTech Connect

The NDA participated in a panel session 31B on Wednesday afternoon starting at 3:15. The NDA is a non-departmental public body, set up in April 2005 under the Energy Act 2004 to take strategic responsibility for the UK's nuclear legacy. Details of their organization and history are located on their web site at www.nda.gov.uk. Also copies of their Power Point presentations made at WM'06 are available on their web site. Their core objective is to ensure that the 20 civil public sector nuclear sites under our ownership are decommissioned and cleaned up safely, securely, cost effectively and in ways that protect the environment for this and future generations. They lead the development of a unified and coherent decommissioning strategy, working in partnership with regulators and site licensees to achieve best value, optimum impact on local communities, and the highest environmental standards. The NDA's main task is the decommissioning and clean up of civil nuclear sites. If the Government decides it is necessary, however, the Energy Act 2004 allows the NDA to take responsibility for sites currently operated by, or on behalf of, the Ministry of Defence (MoD). Resources will then be transferred from the MoD to meet the costs of clean up. The NDA made a number of presentations to allow conference delegates the opportunity to understand some of the major aspects of their work and to interact with NDA staff. These included the following topics and gave opportunity for audience discussion: - A brief presentation to update on progress by the NDA; - Outline of low level waste management and the prioritisation process; - Discussion of the competition schedule related to low level waste management and the Drigg site. The following presentations and handout were delivered in various sessions of the conference as noted below and are available on their web page including the WM'06 Plenary Session presentation by Sir Anthony Cleaver, Chairman of the NDA. During Session 31B, the following Power Point presentations were made. NDA Overview by David Hayes, Director of Special Projects National M and O Contractor Work Prioritisation Process by Mark Wareing, including topics on: - Need for prioritisation; - Development of the process; - Using the process as a measure of progress. Competition by Ron Gorham, Head of Procurement, including topics on: - The current model; - What NDA are actually competing; - The acquisition process; - NDA aspirations for competition; - NDA aspirations from the market. Low Level Waste Contracting in the UK by Adrian Simper, Expenditure and Programme Strategy Manager, including topics on: - Low Level Waste: NDA responsibilities, Definitions, Arisings; - Proposed NDA Procurement for LLW Management: Scope, Contracting approach, Timetable. The NDA responded to questions from the audience and also announced that the NDA will be holding a special Industry Day for potential contractors interested in the first NDA competition - the Low Level Waste Repository near Drigg in Cumbria. The event is scheduled on the 25-26 April 2006 with more details on their web site at www.nda.gov.uk. (authors)

Benda, Gary; Hayes, David; Gorham, Ron; Wareing, Mark; Simper, Adrian; Selby, Terry

2006-07-01

104

The efficacy of micronutrient supplementation in reducing the prevalence of anaemia and deficiencies of zinc and iron among adolescents in Sri Lanka  

Technology Transfer Automated Retrieval System (TEKTRAN)

Objective: To determine the effectiveness of combined iron and zinc over the iron- or zinc-only supplementation in correcting deficiency and possible interactive effects in a group of adolescent school children. Subjects and methods: Schoolchildren (n=821) of 12–16 years of age were randomized into ...

105

Testosterone prohormone supplements.  

PubMed

Testosterone prohormones such as androstenedione, androstenediol, and dehydroepiandrosterone (DHEA) have been heavily marketed as testosterone-enhancing and muscle-building nutritional supplements for the past decade. Concerns over the safety of prohormone supplement use prompted the United States Food and Drug Administration to call for a ban on androstenedione sales, and Congress passed the Anabolic Steroid Control Act of 2004, which classifies androstenedione and 17 other steroids as controlled substances. As of January 2005, these substances cannot be sold without prescription. Here, we summarize the current scientific knowledge regarding the efficacy and safety of prohormone supplementation in humans. We focus primarily on androstenedione, but we also discuss DHEA, androstenediol, 19-nor androstenedione, and 19-nor androstenediol supplements. Contrary to marketing claims, research to date indicates that the use of prohormone nutritional supplements (DHEA, androstenedione, androstenediol, and other steroid hormone supplements) does not produce either anabolic or ergogenic effects in men. Moreover, the use of prohormone nutritional supplements may raise the risk for negative health consequences. PMID:16888459

Brown, Gregory A; Vukovich, Matthew; King, Douglas S

2006-08-01

106

The impact of highly concentrated Mo and Cu dietary supplements, fed as a bolus, on the efficacy of chelated versus inorganic Cu in cattle on a low-Cu diet.  

PubMed

Abstract AIM: To compare the efficacy of chelated versus inorganic forms of dietary Cu supplements, fed as a bolus, when challenged by a daily bolus of dietary Mo in cattle on a low-Cu diet. METHODS: Forty non-lactating, Friesian dairy cows of adequate Cu status were assigned to four groups and fed a basal diet of baled silage containing 5.3 mg Cu and 0.4 mg Mo/kg DM. The experimental design was a factorial of two chemical forms of supplemental Cu and two levels of Mo intake, provided as pelleted grain supplements made from crushed barley/molasses plus Cu and Mo. The supplements contained 140 mg Cu/kg as Cu sulphate pentahydrate (CS), 140 mg Cu/kg as Cu glycinate (CG), CS plus 38 mg Mo/kg as sodium molybdate (CS+Mo), or CG plus 38 mg Mo/kg (CG+Mo). Commencing on Day 0, supplements were fed once daily (offered 1-1.2 kg/cow) and were completely consumed within 5-10 minutes, which constitutes a bolus type of administration. Liver samples were collected by biopsy at Days -24, 13, 41 or 47, and 69 for Cu determinations. RESULTS : The diets fed to the Cu+Mo groups were roughly equivalent to 25 mg Cu and 5.7 mg Mo/kg DM. Mean initial concentration of Cu in liver for all groups was 516 (SE 54) ?mol Cu/kg fresh tissue. In cows supplemented with CS and CG, the final (Day 69) concentrations increased (p<0.01) to 939 (SE 166) and 853 (SE 163) ?mol Cu/kg, respectively. These values were not different (p=0.72). For groups CS+Mo and CG+Mo, the final concentrations of 535 (SE 122) and 453 (SE 102) ?mol Cu/kg were not different from initial values or from each other (p>0.25). The rate of accumulation of Cu in liver following bolus Cu and Mo intake was highly variable but was not affected by initial concentration of Cu in liver (p>0.9) or by the form of Cu (p>0.6). Mean rates of accumulation of Cu in liver were 4.0 (SD 3.8) and 0.65 (SD 2.0) ?mol Cu/kg fresh tissue/day for the Cu-only treatments and the Cu+Mo treatments, respectively. CONCLUSIONS: When fed together as a bolus, high Mo intake negated the effect of supplemental Cu but it did not reduce liver Cu stores. There was no difference in the reaction of dietary Mo with chelated Cu (as glycinate) versus inorganic Cu (as sulphate) dietary supplements. PMID:23442050

Grace, Nd; West, Dm; Smith, Sl; Knowles, So

2013-02-27

107

1 NDA 21-015 Medical Officer's Memorandum: Post-Marketing ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... Issue To: NDA File From: Harry Handelsman, DO; Medical Officer Division of Reproductive and Urologic Products (DRUP) ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

108

FDA Presentation sNDA 21641(013):Rasagiline Delayed Start ...  

Center for Biologics Evaluation and Research (CBER)

Text Version1 FDA Presentation sNDA 21641(013):Rasagiline Delayed Start Trials in Parkinson's Disease Peripheral and Central Nervous System Drugs ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

109

Nutrition and dietary supplements.  

PubMed

Quality and number of subjects in blinded controlled clinical trials about the nutrition and dietary supplements discussed here is variable. Glucosamine sulfate and chondroitin sulfate have sufficient controlled trials to warrant their use in osteoarthritis, having less side effects than currently used nonsteroidal anti-inflammatory drugs, and are the only treatment shown to prevent progression of the disease. Dietary supplements of ephedrine plus caffeine for weight loss (weight loss being the current first line recommendation of physicians for osteoporosis) show some promise, but are not sufficient in number of study subjects. Phenylpropanolamine is proven successful in weight loss. Both ephedrine and phenylpropanolamine have resulted in deaths and hence are worrisome [table: see text] as an over-the-counter dietary supplement. Other commonly used weight loss supplements like Cola acuminata, dwarf elder, Yohimbine, and Garcinia camborgia are either lacking controlled clinical trials, or in the case of the last two supplements, have clinical trials showing lack of effectiveness (although Garcinia has been successful in trials as part of a mixture with other substances, it is unclear if it was a necessary part of the mixture). Safety of these weight loss supplements is unknown. Chromium as a body building supplement for athletes appears to have no efficacy. Creatine may help more in weight lifting than sprinting, but insufficient study subjects and safety information make more studies necessary. Carbohydrate loading is used commonly before endurance competitions, but may be underused as it may be beneficial for other sport performances. Supplements for muscle injury or cramps have had too few studies to determine efficacy. Although proper rehydration with fluids and electrolytes is necessary, a paucity of actual studies to maximize prophylactic treatment for exercise induced cramping still exists. Nutritional supplements for cardiovascular disorders are generally geared to prevention. The United States Department of Agriculture has good recommendations to prevent atherosclerosis; a stricter version by Ornish was shown to reverse coronary heart disease, and the low meat, high fruit, and vegetable DASH diet has been found to decrease hypertension. The epidemiologic studies of hyperhomocysteinemia are impressive enough to give folic acid (or vitamin B6 or B12) supplements to those with elevated homocysteine levels and test patients who have a history of atherosclerotic disease, but no controlled clinical trials have been completed. Soluble fiber has several positive studies in reduction of cholesterol levels and generally is accepted. The data on vitamin E are the most confusing. This vitamin was not helpful in cerebrovascular prevention in China and not helpful at relatively small doses (50 mg) in the United States or Finland against major coronary events. Levels of 400 mg appeared to decrease cardiovascular disease in the United States in studies based on reports by patients and in one large clinical trial. Vitamin E also was successful in prevention of restenosis after PTCA in one clinical trial. Both of these clinical trials need to be repeated in other developed country populations. Some nutritional and dietary supplements are justifiably useful at this point in time. Several meet the criteria of a late Phase 3 FDA clinical trial (where it would be released for public use), but many dietary supplements have insufficient numbers of studies. Some deaths also have occurred with some supplements. If these supplements were required to undergo clinical trials necessary for a new drug by the FDA, they would not be released yet to the public. Several nontoxic supplements appear promising, though need further study. Because they have essentially no toxicity (such as folic acid with B12, soluble fiber, and vitamin E) and may have efficacy, some of these supplementations may be useful now, without randomized clinical trials. PMID:10516985

Fillmore, C M; Bartoli, L; Bach, R; Park, Y

1999-08-01

110

Review and Ranking of NDA Techniques to Determine Plutonium Content in Spent Fuel  

SciTech Connect

A number of efforts are under way to improve nondestructive assay (NDA) techniques for spent nuclear fuel (SNF) safeguard applications. These efforts have largely focused on advancing individual NDA approaches to assay plutonium content. Although significant improvements have been made in NDA techniques, relatively little work has been done to thoroughly and systematically compare the methods. A comparative review of the relative strengths and weaknesses of current NDA techniques brings a new perspective to guide future research. To gauge the practicality and effectiveness of the various relevant NDA approaches, criteria have been developed from two broad categories: functionality and operability. The functionality category includes accuracy estimates, measurement time, plutonium verification capabilities, and assembly or fuel rod assay. Since SNF composition changes with operational history and cooling times, the viability of certain NDA approaches will also change over time. While active interrogation approaches will benefit from reduced background radiation, passive assays will lose the information contained in short-lived isotopes. Therefore, the expected assay accuracy as a function of time is considered. The operability category attempts to gauge the challenges associated with the application of different NDA techniques. This category examines the NDA deploy-ability, measurement capabilities and constraints in spent fuel pools, required on-site facilities, NDA technique synergies, and the extent to which the measurements are obtrusive to the facility. Each topic listed in the categories will be given a numerical score used to rank the different NDA approaches. While the combined numerical score of each technique is informative, the individual-topic scoring will allow for a more-tailored ranking approach. Since the needs and tools of the International Atomic Energy Agency differ from those of a recycling facility, the best assay technique may change with users and SNF characteristics. This ranking system will also examine the merits of a staged inspection with quick measurements followed by more-accurate assays of suspicious SNF. The final results of this ranking process will be used to guide the NDA safeguards research at Oak Ridge National Laboratory.

Cheatham, Jesse R [ORNL; Wagner, John C [ORNL

2010-01-01

111

Improving the Efficacy of the Sterile Insect Technique for Fruit Flies by Incorporation of Hormone and Dietary Supplements into Adult Holding Protocols  

Microsoft Academic Search

The sterile insect technique (SIT) is a universally accepted method of control for tephritid flies. Improving efficacy of\\u000a mating by sterile males would reduce costs significantly. This paper describes studies of the physiological mechanisms responsible\\u000a for coordination of reproductive maturity and sex pheromone communication in males of the genus Anastrepha in order to develop methods for acceleration of reproductive maturity

P. E. A. Teal; Y. Gomez-Simuta; B. D. Dueben; T. C. Holler; S. Olson

112

Efficacy of Supplementation of a Phytase-Producing Bacterial Culture on the Performance and Nutrient Use of Broiler Chickens Fed Corn-Soybean Meal Diets  

Microsoft Academic Search

We evaluated the efficacy of supplementa- tion of active Mitsuokella jalaludinii culture (AMJC) on the growth performance, nutrient use, and mineral concen- trations in tibia bone and plasma of broiler chickens fed corn-soybean meal diets. Dietary treatments included low-nonphytate P (NPP) feed (containing 0.24% and 0.232% NPP for chicks from 1 to 21 and 22 to 42 d of age,

G. Q. Lan; N. Abdullah; S. Jalaludin; Y. W. Ho

113

Effects of NDA, a new plant growth retardant, on cell culture growth of Zea mays L  

Microsoft Academic Search

A new plant growth retardant, the norbornenodiazetine derivative 5-(4-chlorophenyl) - 3,4,5,9,10 - pentaaza - tetracyclo -\\u000a 5,4,1,02.6,08.11- dodeca - 3,9 - diene (NDA) was tested for its effects on growth ofZea mays suspension cultures. It was shown that NDA could inhibit cell division almost completely at a concentration of 5× 10?5 M, while 80% of cells could be considered viable.

Klaus Grossmann; Wilhelm Rademacher; Johannes Jung

1983-01-01

114

CSER 94-015: New portable NDA equipment for use in SNM audits  

SciTech Connect

A criticality safety review is presented for the use of two portable NDA detectors from Los Alamos during an IAEA inspection of the SNM at PFP. The units are an Active Well Coincidence Counter (AWCC) and a High Level Neutron Coincidence Counter (HLNCC). Approval for their employment is based on the inherent safety of the containers to be assayed, one at a time, and because their designs conform with the acceptability criteria which allow the other NDA detectors currently employed at the facility.

Hess, A.L.

1994-12-12

115

Medium-chain acyl-CoA dehydrogenase deficiency: metabolic effects and therapeutic efficacy of long-term L-carnitine supplementation.  

PubMed

Medium-chain acyl-CoA dehydrogenase deficiency is a recently described inborn error of metabolism characterized by episodes of coma and hypoketotic hypoglycaemia in response to prolonged fasting. Secondary carnitine deficiency has been documented in these patients as well as the excretion in the urine of medium-chain-length acyl carnitine esters, such as octanoylcarnitine. Based on the potential toxicity of medium-chain fatty acid metabolites and the beneficial responses of patients with other inborn errors of metabolism and secondary carnitine deficiency, oral carnitine has been proposed as treatment for children with medium-chain acyl-CoA dehydrogenase deficiency. We report the results of carefully monitored fasting challenges of an infant with this deficiency both before and after 3 months of oral carnitine therapy. Carnitine supplementation failed to prevent lethargy, vomiting, hypoglycaemia and accumulation of free fatty acids in response to fasting despite normalization of plasma carnitine levels and a marked increase in urinary excretion of acyl-carnitine esters. Potentially toxic medium-chain fatty acids accumulated in the plasma in spite of therapy. Based on this study of one patient, we stress that avoidance of fasting and prompt institution of glucose supplementation in situations when oral intake is interrupted remain the mainstays of therapy for medium-chain acyl-CoA dehydrogenase deficient patients. PMID:2502671

Treem, W R; Stanley, C A; Goodman, S I

1989-01-01

116

Dietary Supplements  

MedlinePLUS

Dietary supplements are vitamins, minerals, herbs, and many other products. They can come as pills, capsules, powders, drinks, ... possible Tell your health care provider about any dietary supplements you use Do not take a bigger dose ...

117

Efficacy of a 2-month dietary supplementation with polyunsaturated fatty acids in dry eye induced by scopolamine in a rat model  

Microsoft Academic Search

Background  This study was conducted to evaluate the efficacy of dietary n-6 and n-3 polyunsaturated fatty acids (PUFAs) in dry eye in\\u000a a rat model.\\u000a \\u000a \\u000a \\u000a Methods  Female Lewis rats were fed with diets containing (1) ?-linolenic acid (GLA), (2) eicosapentaenoic acid (EPA) + docosahexaenoic\\u000a acid (DHA), or (3) GLA + EPA + DHA, for 2 months before the induction of dry eye using

Sabrina Viau; Marie-Annick Maire; Bruno Pasquis; Stéphane Grégoire; Niyazi Acar; Alain M. Bron; Lionel Bretillon; Catherine P. Creuzot-Garcher; Corinne Joffre

2009-01-01

118

WRITTEN REQUEST – AMENDMENT # 4 IND IND IND NDA ...  

Center for Drug Evaluation (CDER)

Text Version... STUDY 1: PHARMACOKINETIC (PK), PHARMACODYNAMIC (PD), EFFICACY, AND SAFETY STUDY IN PEDIATRIC PATIENTS LESS THAN 12 ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

119

Dietary supplements  

Microsoft Academic Search

For the athlete training hard, nutritional supplements are often seen as promoting adaptations to training, allowing more consistent and intensive training by promoting recovery between training sessions, reducing interruptions to training because of illness or injury, and enhancing competitive performance. Surveys show that the prevalence of supplement use is widespread among sportsmen and women, but the use of few of

RON J. MAUGHAN; DOUG S. KING; Trevor Lea

2004-01-01

120

Dietary supplements.  

PubMed

For the athlete training hard, nutritional supplements are often seen as promoting adaptations to training, allowing more consistent and intensive training by promoting recovery between training sessions, reducing interruptions to training because of illness or injury, and enhancing competitive performance. Surveys show that the prevalence of supplement use is widespread among sportsmen and women, but the use of few of these products is supported by a sound research base and some may even be harmful to the athlete. Special sports foods, including energy bars and sports drinks, have a real role to play, and some protein supplements and meal replacements may also be useful in some circumstances. Where there is a demonstrated deficiency of an essential nutrient, an increased intake from food or from supplementation may help, but many athletes ignore the need for caution in supplement use and take supplements in doses that are not necessary or may even be harmful. Some supplements do offer the prospect of improved performance; these include creatine, caffeine, bicarbonate and, perhaps, a very few others. There is no evidence that prohormones such as androstenedione are effective in enhancing muscle mass or strength, and these prohormones may result in negative health consequences, as well as positive drug tests. Contamination of supplements that may cause an athlete to fail a doping test is widespread. PMID:14971436

Maughan, Ron J; King, Doug S; Lea, Trevor

2004-01-01

121

Automatic identification of NDA measured items: Use of E-tags  

NASA Astrophysics Data System (ADS)

This paper describes how electronic identification devices or E-tags could reduce the time spent by International Atomic Energy Agency (IAEA) inspectors making nondestructive assay (NDA) measurements. As one example, the use of E-tags with a high-level neutron coincidence counter (HLNC) is discussed in detail. Sections of the paper include inspection procedures, system description, software, and future plans. Mounting of E-tabs, modifications to the HLNC, and the use of tamper indicating devices are also discussed. The technology appears to have wide application to different types of nuclear facilities and inspections and could significantly change NDA inspection procedures.

Chitumbo, K.; Olsen, R.; Hatcher, C. R.; Kadner, S. P.

122

Dietary Supplements and Sports Performance: Herbals  

PubMed Central

This is the fourth in a series of six articles to discuss the major classes of dietary supplements (vitamins; minerals; amino acids; herbs or botanicals; metabolites, constituents/extracts, or combinations). The major focus is on efficacy of such dietary supplements to enhance exercise or sport performance.

Williams, Melvin

2006-01-01

123

Dietary Supplements and Sports Performance: Amino Acids  

Microsoft Academic Search

This is the third in a series of six articles to discuss the major classes of dietary supplements (vitamins; minerals; amino acids; herbs or botanicals; metabolites, constituents\\/extracts, or combinations). The major focus is on efficacy of such dietary supplements to enhance exercise or sport performance.

Melvin Williams

2005-01-01

124

Dietary Supplements and Sports Performance: Herbals  

Microsoft Academic Search

This is the fourth in a series of six articles to discuss the major classes of dietary supplements (vitamins; minerals; amino\\u000a acids; herbs or botanicals; metabolites, constituents\\/extracts, or combinations). The major focus is on efficacy of such dietary\\u000a supplements to enhance exercise or sport performance.

Melvin Williams

2006-01-01

125

Dietary Supplements and Sports Performance: Amino Acids  

PubMed Central

This is the third in a series of six articles to discuss the major classes of dietary supplements (vitamins; minerals; amino acids; herbs or botanicals; metabolites, constituents/extracts, or combinations). The major focus is on efficacy of such dietary supplements to enhance exercise or sport performance.

Williams, Melvin

2005-01-01

126

Methionine Supplementation Options in Poultry  

Microsoft Academic Search

2 Abstract: Methionine is essential or limiting amino acid for poultry. An experiment was conducted to determine the comparative efficacy of DL-methionine and herbal methionine supplement on growth and performance of broiler chickens. Three hundred commercial broiler (VenCobb) chicks were procured and randomly divided into three groups (n = 100), one control (T ) and two treatments (T and T

V. H. Kalbande; K. Ravikanth; S. Maini; D. S. Rekhe

2009-01-01

127

The efficacy and safety study of dietary supplement PURIAM110 on non-insulin taking Korean adults in the stage of pre-diabetes and diabetes mellitus: protocol for a randomized, double-blind, placebo-controlled, and multicenter trial-pilot study  

PubMed Central

Background Diabetes has already become a threat to the nation and the individual due to its high prevalence rates and high medical expenses. Therefore, preventing diabetes at an earlier stage is very important. Despite advances in antidiabetic agents, we have not yet achieved any satisfying results in treating diabetes. Among various treatments, medicinal herbs and supplements for diabetes are reported to show generally good efficacy and safety data. In particular, PURIAM110, a compound from orange fruits and mulberry leaves, is supposed to prevent the progress of type II diabetes mellitus and improve diabetic symptoms. This is the first reported pilot study about the protective effect of the orange fruits and mulberry leaves mixture against pre-diabetes on Korean adults. Based on these positive results of herb-derived components, extended studies of dietary supplements have to be done to suggest confirmative evidences. Methods/Design The efficacy and safety study of PURIAM110 is a double-blinded, placebo-controlled, randomized, and multi-center clinical trial. A total of 45 subjects will participate in this study for 6 weeks. Discussion The present protocol will confirm the efficacy and safety of PURIAM110 for pre-diabetes, suggesting more basic knowledge to conduct further randomized controlled trials (RCT). In addition, PURIAM110 can be an alternative dietary supplemental remedy for diabetes patients. Trial Registration ISRCTN: ISRCTN44779824

2011-01-01

128

Sports Supplements  

MedlinePLUS

... supplements. Instead, try these tips for getting better game: Make downtime a priority. Studies show that teens ... Meditating or visualizing your success during the next game may improve your performance; sitting quietly and focusing ...

129

Calcium supplements  

MedlinePLUS

... the word "purified" or the United States Pharmacopeia (USP) symbol. Watch out for supplements made from unrefined ... meal, or dolomite that don't have the USP symbol. They may have high levels of lead ...

130

Dietary Supplements  

Center for Food Safety and Applied Nutrition (CFSAN)

Text Version... The manufacturers and distributors of dietary supplements are responsible for making sure their products are safe BEFORE they go to market. ... More results from www.fda.gov/downloads/food/dietarysupplements

131

Colostrum supplement  

US Patent & Trademark Office Database

A consumable supplement contains a colostrum component composed of processed bovine colostrum, magnesium peroxide as a source of active oxygen, a vitamin such as vitamin C, magnesium succinate and a bioflavonoid. This colostrum component can be taken separately or admixed with other minerals, vitamins and the like. In one form, the colostrum component is used as an outer shell for a composite pill, tablet or capsule which includes an inner core containing one or more vitamins, minerals, enzymes or omega acids in the event that the components of the inner core are incompatible with one or more materials of the colostrum component. In this way, a wide variety of supplements may be provided offering the advantages of colostrum and active oxygen and the advantages of other materials which may be taken as a single pill or capsule. Various supplements and formulations are described as well as various amounts of the varius components of the supplement.

1998-12-08

132

Dietary Supplements  

Center for Food Safety and Applied Nutrition (CFSAN)

Text Version... So, be sure to inform your health-care provider, including your pharmacist, about any supplements you are taking — especially before surgery. ... More results from www.fda.gov/downloads/food/resourcesforyou

133

Creatine supplementation.  

PubMed

Creatine monohydrate is a dietary supplement that increases muscle performance in short-duration, high-intensity resistance exercises, which rely on the phosphocreatine shuttle for adenosine triphosphate. The effective dosing for creatine supplementation includes loading with 0.3 g·kg·d for 5 to 7 days, followed by maintenance dosing at 0.03 g·kg·d most commonly for 4 to 6 wk. However loading doses are not necessary to increase the intramuscular stores of creatine. Creatine monohydrate is the most studied; other forms such as creatine ethyl ester have not shown added benefits. Creatine is a relatively safe supplement with few adverse effects reported. The most common adverse effect is transient water retention in the early stages of supplementation. When combined with other supplements or taken at higher than recommended doses for several months, there have been cases of liver and renal complications with creatine. Further studies are needed to evaluate the remote and potential future adverse effects from prolonged creatine supplementation. PMID:23851411

Hall, Matthew; Trojian, Thomas H

134

Safety and Efficacy of the Nonsystemic Chewable Complex Carbohydrate Dietary Supplement PAZ320 on Postprandial Glycemia When Added to Oral Agents or Insulin in Patients with Type 2 Diabetes Mellitus.  

PubMed

Objective: Our primary objective was to evaluate the effect of the dietary supplement PAZ320 on postprandial glucose excursion. PAZ320 is derived from glucomannan and acts by blocking carbohydrate hydrolyzing enzymes and by binding to ingested polysaccharides. Endpoints included area under the curve during postprandial glucose excursion (gAUC) and adverse reactions.Methods: In an open-label, sequential dose-escalation, prospective study, we examined the efficacy and safety of PAZ320 in 24 subjects with type 2 diabetes treated with oral agents and/or insulin. Subjects consumed 75 g jasmine rice alone or with low-dose (8 g) or high-dose (16 g) PAZ320. A real-time blinded continuous glucose monitor (CGM) was used to assess 3-hour postprandial glycemia.Results: We found that 45% of subjects responded to high-dose PAZ320 as evidenced by a decrease in gAUC of 40% compared to baseline in a dose-dependent manner. The effect of PAZ320 does not correlate with duration of diabetes and seems to work regardless of concurrent diabetes medications. The responders had higher postmeal glucose elevation at baseline, while the nonresponders showed no effect or paradoxic glucose response to PAZ320. There was no severe hypoglycemia, and the gastrointestinal side effects were mild.Conclusions: PAZ320 may be useful as an adjunct to decrease postprandial glycemia in type 2 diabetes, although patients should verify its effect on postprandial glucose due to a possible paradoxic response. Its safety profile is reassuring. Further study is required to determine its long-term effects on glycated hemoglobin (HbA1c) and to further define which subpopulation may respond to PAZ320. PMID:23425645

Trask, Laura E; Kasid, Natasha; Homa, Karen; Chaidarun, Sushela

135

Performance enhancement with supplements: incongruence between rationale and practice  

Microsoft Academic Search

BACKGROUND: Athletes are expected to consider multiple factors when making informed decision about nutritional supplement use. Besides rules, regulations and potential health hazards, the efficacy of different nutritional supplements in performance enhancement is a key issue. The aim of this paper was to find evidence for informed decision making by investigating the relationship between specific performance-related reasons for supplement use

Andrea Petróczi; Declan P Naughton; Jason Mazanov; Allison Holloway; Jerry Bingham

2007-01-01

136

Creating NDA working standards through high-fidelity spent fuel modeling  

SciTech Connect

The Next Generation Safeguards Initiative (NGSI) is developing advanced non-destructive assay (NDA) techniques for spent nuclear fuel assemblies to advance the state-of-the-art in safeguards measurements. These measurements aim beyond the capabilities of existing methods to include the evaluation of plutonium and fissile material inventory, independent of operator declarations. Testing and evaluation of advanced NDA performance will require reference assemblies with well-characterized compositions to serve as working standards against which the NDA methods can be benchmarked and for uncertainty quantification. To support the development of standards for the NGSI spent fuel NDA project, high-fidelity modeling of irradiated fuel assemblies is being performed to characterize fuel compositions and radiation emission data. The assembly depletion simulations apply detailed operating history information and core simulation data as it is available to perform high fidelity axial and pin-by-pin fuel characterization for more than 1600 nuclides. The resulting pin-by-pin isotopic inventories are used to optimize the NDA measurements and provide information necessary to unfold and interpret the measurement data, e.g., passive gamma emitters, neutron emitters, neutron absorbers, and fissile content. A key requirement of this study is the analysis of uncertainties associated with the calculated compositions and signatures for the standard assemblies; uncertainties introduced by the calculation methods, nuclear data, and operating information. An integral part of this assessment involves the application of experimental data from destructive radiochemical assay to assess the uncertainty and bias in computed inventories, the impact of parameters such as assembly burnup gradients and burnable poisons, and the influence of neighboring assemblies on periphery rods. This paper will present the results of high fidelity assembly depletion modeling and uncertainty analysis from independent calculations performed using SCALE and MCNP. This work is supported by the Next Generation Safeguards Initiative, Office of Nuclear Safeguards and Security, National Nuclear Security Administration.

Skutnik, Steven E [ORNL; Gauld, Ian C [ORNL; Romano, Catherine E [ORNL; Trellue, Holly [Los Alamos National Laboratory (LANL)

2012-01-01

137

Dietary supplements in weight reduction.  

PubMed

We summarize evidence on the role of dietary supplements in weight reduction, with particular attention to their safety and benefits. Dietary supplements are used for two purposes in weight reduction: (a) providing nutrients that may be inadequate in calorie-restricted diets and (b) for their potential benefits in stimulating weight loss. The goal in planning weight-reduction diets is that total intake from food and supplements should meet recommended dietary allowance/adequate intake levels without greatly exceeding them for all nutrients, except energy. If nutrient amounts from food sources in the reducing diet fall short, dietary supplements containing a single nutrient/element or a multivitamin-mineral combination may be helpful. On hypocaloric diets, the addition of dietary supplements providing nutrients at a level equal to or below recommended dietary allowance/adequate intake levels or 100% daily value, as stated in a supplement's facts box on the label, may help dieters to achieve nutrient adequacy and maintain electrolyte balance while avoiding the risk of excessive nutrient intakes. Many botanical and other types of dietary supplements are purported to be useful for stimulating or enhancing weight loss. Evidence of their efficacy in stimulating weight loss is inconclusive at present. Although there are few examples of safety concerns related to products that are legal and on the market for this purpose, there is also a paucity of evidence on safety for this intended use. Ephedra and ephedrine-containing supplements, with or without caffeine, have been singled out in recent alerts from the Food and Drug Administration because of safety concerns, and use of products containing these substances cannot be recommended. Dietitians should periodically check the Food and Drug Administration Web site ( www.cfsan.fda.gov ) for updates and warnings and alert patients/clients to safety concerns. Dietetics professionals should also consult authoritative sources for new data on efficacy as it becomes available ( ods.od.nih.gov ). PMID:15867902

Dwyer, Johanna T; Allison, David B; Coates, Paul M

2005-05-01

138

Dietary supplement drug therapies for depression.  

PubMed

Many dietary supplements are readily accessible and commonly used for the treatment of depression. A dietary supplement is a product intended to supplement the diet but is not intended to treat, diagnose, prevent, or cure disease. The U.S. Food and Drug Administration can take action against dietary supplement manufacturers for products only after they are marketed, mainly if the product is found to be unsafe or if false or misleading claims are made about the product. Few dietary supplement products have been adequately studied for their safety and efficacy. Of the five products reviewed in this article (L-methylfolate, S-adenosyl-L-methionine [SAM-e], omega-3 fatty acids, L-tryptophan, and inositol), only omega-3 fatty acids and SAM-e have sufficient supporting evidence for their efficacy to warrant safe use. PMID:22589230

Howland, Robert H

2012-05-18

139

Cardiovascular effects of calcium supplements.  

PubMed

Calcium supplements reduce bone turnover and slow the rate of bone loss. However, few studies have demonstrated reduced fracture incidence with calcium supplements, and meta-analyses show only a 10% decrease in fractures, which is of borderline statistical and clinical significance. Trials in normal older women and in patients with renal impairment suggest that calcium supplements increase the risk of cardiovascular disease. To further assess their safety, we recently conducted a meta-analysis of trials of calcium supplements, and found a 27%-31% increase in risk of myocardial infarction, and a 12%-20% increase in risk of stroke. These findings are robust because they are based on pre-specified analyses of randomized, placebo-controlled trials and are consistent across the trials. Co-administration of vitamin D with calcium does not lessen these adverse effects. The increased cardiovascular risk with calcium supplements is consistent with epidemiological data relating higher circulating calcium concentrations to cardiovascular disease in normal populations. There are several possible pathophysiological mechanisms for these effects, including effects on vascular calcification, vascular cells, blood coagulation and calcium-sensing receptors. Thus, the non-skeletal risks of calcium supplements appear to outweigh any skeletal benefits, and are they appear to be unnecessary for the efficacy of other osteoporosis treatments. PMID:23857224

Reid, Ian R

2013-07-05

140

ML-oriented NDA carrier synchronization for general rotationally symmetric signal constellations  

Microsoft Academic Search

We point out that the nondecision-aided (NDA) carrier synchronizer, maximizing the low Es\\/No limit of the likelihood function averaged over a general 2?\\/N-rotationally symmetric signal constellation, reduces to the familiar timing-aided Nth power synchronizer; this extends a result of D'Andrea, Mengali and Reggiannini (1988) where only M-PSK constellations have been considered. Whereas in the case of M-PSK the tracking error

Marc Moeneclaey; Geert de Jonghe

1994-01-01

141

‹drar Örneklerinden ‹zole Edilen Toplum ve Hastane Kaynakl› Escherichia coli Sufllar›nda Antibiyotik Direnci  

Microsoft Academic Search

Gerek toplum kaynakl› gerekse hastane kaynakl› üriner sistem infeksiyonlar›nda en s›k izo- le edilen etken Escherichia coli'dir. Bu çal›flma, bölgemizdeki Escherichia coli sufllar›n›n çe- flitli antibiyotiklere direnç durumlar›n›n belirlenmesi ve ampirik tedavi seçeneklerinde yol gösterici olmas› amac›yla yap›lm›flt›r. 129 toplum kökenli, 120 hastane kökenli suflun, \\

Füsun Zeynep; Onur KAYA; Güler YAYLI

2004-01-01

142

Conceptual designs of NDA instruments for the NRTA system at the Rokkasho Reprocessing Plant  

SciTech Connect

The authors are studying conceptual designs of selected nondestructive assay (NDA) instruments for the near-real-time accounting system at the rokkasho Reprocessing Plant (RRP) of Japan Nuclear Fuel Limited (JNFL). The JNFL RRP is a large-scale commercial reprocessing facility for spent fuel from boiling-water and pressurized-water reactors. The facility comprises two major components: the main process area to separate and produce purified plutonium nitrate and uranyl nitrate from irradiated reactor spent fuels, and the co-denitration process area to combine and convert the plutonium nitrate and uranyl nitrate into mixed oxide (MOX). The selected NDA instruments for conceptual design studies are the MOX-product canister counter, holdup measurement systems for calcination and reduction furnaces and for blenders in the co-denitration process, the isotope dilution gamma-ray spectrometer for the spent fuel dissolver solution, and unattended verification systems. For more effective and practical safeguards and material control and accounting at RRP, the authors are also studying the conceptual design for the UO{sub 3} large-barrel counter. This paper discusses the state-of-the-art NDA conceptual design and research and development activities for the above instruments.

Li, T.K.; Klosterbuer, S.F.; Menlove, H.O. [Los Alamos National Lab., NM (United States). Safeguards Science and Technology Group] [and others

1996-09-01

143

Analysis of historical delta values for IAEA/LANL NDA training courses  

SciTech Connect

The Los Alamos National Laboratory (LANL) supports the International Atomic Energy Agency (IAEA) by providing training for IAEA inspectors in neutron and gamma-ray Nondestructive Assay (NDA) of nuclear material. Since 1980, all new IAEA inspectors attend this two week course at LANL gaining hands-on experience in the application of NDA techniques, procedures and analysis to measure plutonium and uranium nuclear material standards with well known pedigrees. As part of the course the inspectors conduct an inventory verification exercise. This exercise provides inspectors the opportunity to test their abilities in performing verification measurements using the various NDA techniques. For an inspector, the verification of an item is nominally based on whether the measured assay value agrees with the declared value to within three times the historical delta value. The historical delta value represents the average difference between measured and declared values from previous measurements taken on similar material with the same measurement technology. If the measurement falls outside a limit of three times the historical delta value, the declaration is not verified. This paper uses measurement data from five years of IAEA courses to calculate a historical delta for five non-destructive assay methods: Gamma-ray Enrichment, Gamma-ray Plutonium Isotopics, Passive Neutron Coincidence Counting, Active Neutron Coincidence Counting and the Neutron Coincidence Collar. These historical deltas provide information as to the precision and accuracy of these measurement techniques under realistic conditions.

Geist, William [Los Alamos National Laboratory; Santi, Peter [Los Alamos National Laboratory; Swinhoe, Martyn [Los Alamos National Laboratory; Bonner, Elisa [FORMER N-4 STUDENT

2009-01-01

144

A preliminary evaluation of certain NDA techniques for RH-TRU characterization  

SciTech Connect

This report presents the results of modeling efforts to evaluate selected NDA assay methods for RH-TRU waste characterization. The target waste stream was Content Code 104/107 113-liter waste drums that comprise the majority of the INEL`s RH-TRU waste inventory. Two NDA techniques are treated in detail. One primary NDA technique examined is gamma-ray spectrometry to determine the drum fission and activation product content, and fuel sample inventory calculations using the ORIGEN code to predict the total drum inventory. A heavily shielded and strongly collimated HPGE spectrometer system was designed using MCNP modeling. Detection limits and expected precision of this approach were estimated by a combination of Monte Carlo modeling and synthetic gamma-ray spectrum generation. This technique may allow the radionuclide content of these wastes to be determined with relative standard deviations of 20 to 55% depending on the drum matrix and radionuclide. The INEL Passive/Active Neutron (PAN) assay system is the second primary technique considered. A shielded overpack for the 113-liter CC104/107 RH-TRU drums was designed to shield the PAN detectors from excessive gamma radiation. MCNP modeling suggests PAN detection limits of about 0.06 g {sup 235}U and 0.04 g {sup 239}Pu during active assays.

Hartwell, J.K.; Yoon, W.Y.; Peterson, H.K.

1996-12-31

145

Survey of DOE NDA practices for CH-Tru waste certification--illustrated with a greater than 10,000 drum NDA data base  

SciTech Connect

We have compiled a greater than 10,000 CH-TRU waste drum data base from seven DOE sites which have utilized such multiple NDA measurements within the past few years. Most of these nondestructive assay (NDA) technique assay result comparisons have been performed on well-characterized, segregated waste categories such as cemented sludges, combustibles, metals, graphite residues, glasses, etc., with well-known plutonium isotopic compositions. Waste segregation and categorization practices vary from one DOE site to another. Perhaps the most systematic approach has been in use for several years at the Rocky Flats Plant (RFP), operated by Rockwell International, and located near Golden, Colorado. Most of the drum assays in our data base result from assays of RFP wastes, with comparisons available between the original RFP assays and PAN assays performed independently at the Idaho National Engineering Laboratory (INEL) Solid Waste Examination Pilot Plant (SWEPP) facility. Most of the RFP assays were performed with hyperpure germanium (HPGe)-based SGS assay units. However, at least one very important waste category, processed first-stage sludges, is assayed at RFP using a sludge batch-sampling procedure, prior to filling of the waste drums. 5 refs., 5 figs.

Schultz, F.J.; Caldwell, J.T.; Smith, J.R.

1988-01-01

146

Dietary Supplements for Toddlers  

MedlinePLUS

... Nutrition > Dietary Supplements for Toddlers Ages & Stages Listen Dietary Supplements for Toddlers Article Body If you provide your ... foods, consult your pediatrician about adding an iron supplement to her diet. In the meantime, decrease her milk intake and ...

147

Dietary Supplements and Sports Performance: Metabolites, Constituents, and Extracts  

Microsoft Academic Search

This is the fifth in a series of six articles to discuss the major classes of dietary supplements (vitamins; minerals; amino acids; herbs or botanicals; and metabolites\\/constituents\\/extracts). The major focus is on efficacy of such dietary supplements to enhance exercise or sports performance.

Melvin Williams

2006-01-01

148

Medication and supplement use by athletes.  

PubMed

Athletes are affected in various ways by medications and supplements. Physicians caring for athletes need to be aware of medicines that athletes are taking and how they may interact with performance, exercise, environment, and other medicines. Athletes may attempt to gain a performance advantage with the use of a variety of dietary supplements and performance enhancers. Physicians must be knowledgeable of these so that athletes are properly educated about potential benefits and risks and physical effects. This article first reviews common medicines that athletes use and their potential efficacy and interactions with exercise and environment, then reviews dietary supplements and the data on their efficacy for performance enhancement. Finally, current and future doping issues are discussed. PMID:16004927

Ciocca, Mario

2005-07-01

149

Nutritional Supplements and Doping  

Microsoft Academic Search

Context: The problems of doping in sport and the increasing use of nutritional supplements by athletes are issues that inter- sect to the degree that a large number of supplements may contain substances that are banned in sport. Many supplements contain substances that are associated with significant health hazards. Athletes consuming such supplement products may jeopardize their sporting status, and

Andrew Pipe; Christiane Ayotte

150

Socioeconomic Differentials in Supplementation of Vitamin A: Evidence from the Philippines  

Microsoft Academic Search

The efficacy of supplementation of vitamin A in child survival has been well-demonstrated. However, the effectiveness of a programme of vitamin A supplementation at the population level has been rarely examined. Understanding how programmes reach disadvantaged children can help improve the design of initiatives of vitamin A supplementation. The differentials in receipt of vitamin A by socioecono- mic status were

Yoonjoung Choi; David Bishai; Kenneth Hill

2005-01-01

151

Nutritional supplements and ergogenic AIDS.  

PubMed

Performance enhancing drugs, ergogenic aids, and supplements come in many forms. The financial, personal, social, and health-related impact of these substances has wide and varied consequences. This article reviews common substances and practices used by athletes. It discusses the history, use, effects, and adverse effects of androgenic anabolic steroids, peptide hormones, growth factors, masking agents, diuretics, volume expanders, ?-blockers, amphetamines, caffeine, other stimulants, and creatine. The evidence base behind the use, safety, and efficacy of these items as well as testing for these substances is discussed. PMID:23668655

Liddle, David G; Connor, Douglas J

2013-04-13

152

NDA205123  

Center for Biologics Evaluation and Research (CBER)

Text Version... The attached package contains background information prepared by the Food ... ongoing Phase 3 development programs in Japan, China, and Korea ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

153

Reading Intervention in Middle and High Schools: Implementation Fidelity, Teacher Efficacy, and Student Achievement  

ERIC Educational Resources Information Center

|This study investigated teachers' efficacy and implementation in the context of a supplemental intervention for struggling adolescent readers. It examined teachers' efficacy at the start of their intervention training and investigated relationships among teachers' efficacy, implementation, and students' reading progress. The efficacy and…

Cantrell, Susan Chambers; Almasi, Janice F.; Carter, Janis C.; Rintamaa, Margaret

2013-01-01

154

Sampling and verification methods for the uncertainty analysis of NDA and NDE waste characterization systems  

SciTech Connect

Use of nondestructive assay (NDA) and evaluation (NDE) systems in critical waste characterization requires a realistic assessment of the uncertainty in the measurements. The stated uncertainty must include potential effects of a variety of complicating external factors on the expected bias and precision. These factors include material heterogeneity (matrix effects), fluctuating background levels, and other variable operating conditions. Uncertainty figures from application of error propagation methods to data from controlled laboratory experiments using standard test materials can grossly underestimate the expected error. This paper reviews the standard error propagation method of uncertainty analysis, discusses some of its limitations, and presents an alternative approach based on sampling and verification. Examples of application of sampling and verification methods to measurement systems at INEL are described.

Blackwood, L.G.

1997-01-01

155

Portable NDA Equipment for Enrichment Measurements in the HEU Transparency Program  

SciTech Connect

The Highly Enriched Uranium (HEU) Transparency Program has used portable nondestructive assay (NDA) equipment to measure the {sup 235}U enrichment of material subject to the transparency agreement since 1997. The equipment is based on the 'enrichment meter' method and uses low-resolution sodium iodide (NaI(Tl)) detectors. Although systems using high-purity germanium (HPGe) detectors can produce more accurate results we have found that the results with NaI(Tl) detectors are quite adequate for the requirements of the transparency agreement. This paper will describe the details of the equipment's operation, calibration, testing, and deployment in Russia. We will also provide a comparison of the units originally deployed in 1997 with the upgraded systems that were deployed in 2003.

Decman, D J; Bandong, B B; Wong, J L; Valentine, J D; Luke, S J

2008-06-02

156

NDA measurement of the enrichment of uranium in the pipe for a gas centrifuge enrichment plant  

SciTech Connect

A NDA instrument has been developed to determine the enrichment of gas phase uranium in pipes for a gas centrifuge enrichment plant. The enrichment of gas phase uranium could be measured by combining the passive gamma rays measurement with X-ray fluorescent analysis. The passive gamma rays measurement has extensively been performed in previous works. Successively the amount of deposited uranium has been measured for a long-term plant operation. Some increase of deposited uranium was observed. Determination of total mass of uranium in a pipe was studied by X-ray fluorescent analysis on a test loop system. It was found that total mass of gaseous UF/sub 6/ in the pipe could be determined accurately enough in implementation of safeguards.

Hori, M.; Ishiga, T.; Akiba, M.; Tani, A.; Omae, M.

1986-01-01

157

Efficacy of Nutritional Ergogenic Aids in Hot Environments.  

National Technical Information Service (NTIS)

Many athletes seeking a competitive edge rely on nutritional ergogenic aids to improve performance. Carbohydrate (CHO) and caffeine (CAF) supplementation appear efficacious at enhancing endurance exercise performance when studied under ideal circumstances...

B. R. Ely S. N. Cheuvront

2010-01-01

158

Herbal Products and Supplements  

MedlinePLUS

... minerals, and dietary supplements follow the U.S. Pharmacopeial (USP) Convention quality standards. These supplement manufacturers volunteer to ... additional quality credentials on their labels, such as “USP Verified” or “ConsumerLab.com Approved Quality.” Choose your ...

159

Dietary Supplements Task Force.  

National Technical Information Service (NTIS)

The Dietary Supplements Task Force was charged with examining the issues regarding dietary supplements and developing a regulatory framework for these products. To facilitate the orderly development of regulatory strategies, the Task Force divided the uni...

1992-01-01

160

Dietary supplement use in cancer care: help or harm.  

PubMed

Conventional wisdom generally recommends complete avoidance of all dietary supplements, especially during chemotherapy and radiation. This interdiction persists, in spite of high rates of dietary supplement use by patients throughout all phases of cancer care, and can result in patients' perceptions of physicians as negative, thus leading to widespread nondisclosure of use. A review of the clinical literature shows that some evidence for harm does exist; however, data also exist that show benefit from using certain well-qualified supplements. Physicians should increase their knowledge base about dietary supplement use in cancer and consider all of the data when advising patients. Strategies that are patient-centered and reflect the complete array of available evidence lead to more nuanced messages about dietary supplement use in cancer. This should encourage greater disclosure of use by patients and ultimately increase safety and efficacy for patients choosing to use dietary supplements during cancer care. PMID:18638690

Hardy, Mary L

2008-08-01

161

Dietary Supplements for Osteoarthritis  

Microsoft Academic Search

A large number of dietary supplements are promoted to patients with osteoarthritis and as many as one third of those patients have used a supplement to treat their condition. Glucosamine-containing supplements are among the most commonly used products for osteo- arthritis. Although the evidence is not entirely consistent, most research suggests that glucos- amine sulfate can improve symptoms of pain

Pharm D

162

Kinetics of cure for a coating system including DGEBA ( n = 0)\\/1,8-NDA and barium carbonate  

Microsoft Academic Search

The increasing demand for low-cost and high performance coatings has promoted the development of chip epoxy-based coatings using inert fillers. Attention has been paid here on employing mixtures of DGEBA with barium carbonate as novel ceramic-based filler to produce a coating using 1,8-naphthalene diamine (1,8-NDA) as the crosslinking agent. A substantial increase in the Tg, from 85 to 100°C, is

Abdollah Omrani; Abbas A. Rostami; Esmat Sedaghat

2010-01-01

163

Integrating Herbs and Supplements in Managed Care: A Pharmacy Perspective  

PubMed Central

Herbal and other dietary supplements are popular among patients. Whether and how to establish and manage an herbal formulary remains a challenge for conventional managed-care organizations. Pharmacists and clinicians depend on evidence-based guidelines to help determine which products (whether pharmaceutical or herbal) to make available to patients. Evidence from randomized controlled trials that supports the use of most herbal supplements is scarce, yet for some supplements, credible evidence supports the possibility of efficacy. Quality control remains of concern for the supplement industry and for patients and clinicians considering the use of supplements. Clinicians may improve care by both disseminating educational materials and making available to patients popular quality-controlled herbal supplements deemed safe and effective. Kaiser Permanente Northwest (KPNW) has adopted a comprehensive and systematic approach to managing and stocking herbal supplements that can serve as a model for other conventional and managed care organizations. KPNW's dedicated Natural Products Advisory Committee (NPAC) has made considerable progress toward developing a constructive response to KPNW patients' herbal supplement use. Making supplements available at pharmacies can improve clinical outcomes, patient convenience, and quality control. NPAC currently limits its reviews to randomized, controlled trials and data from meta-analyses and systematic reviews for single-ingredient supplements. As interest in this area maintains steady growth, NPAC will continue to study how best to meet patients' needs.

Elder, Charles; Mossbrucker, Pat; Davino-Ramaya, Carrie M; Bez, Ileana; Lin, Margaret M; Terry, Theresa A; Thomas, Emily A; Jones, Sean

2008-01-01

164

ARIES NDA Suite: Fully-integrated and automated nuclear material assay system for measurement of special nuclear materials  

SciTech Connect

The Advanced Retirement and Integrated Extraction System (ARIES) mission the demonstration of advanced technologies for the integrated dismantlement of surplus nuclear weapon components (pits) and the packaging of the recovered plutonium into long-term storage containers. The unclassified plutonium product is suitable for traditional international safeguards, as well as other potential inspection regimes. As indicated in the recent Secretary of Energy`s Record of Decision (ROD), this unclassified excess material is anticipated to be offered for international safeguards under the US Voluntary Offer (INFCIRC/288) performed by the International Atomic Energy Agency (TAEA). The ARIES nondestructive assay (NDA) suite offers state-of-the-art capabilities that provide highly accurate, precise material assay meeting IAEA bias defect measurement levels. Because of these levels of performance, the requirement of destructive analysis is largely removed. The unique combination of automation and high accuracy suggests the possibility of dual-use operator-owned IAEA authenticated instrumentation. Finally, the concept of continuous unattended monitoring for international safeguards applications with the ARIES NDA suite is intriguing and may encourage additional deployments of similar NDA systems internationally or elsewhere within the DOE complex.

Fearey, B.L.; Sampson, T.E.; Cremers, T.L.

1997-04-01

165

Using NDA Techniques to Improve Safeguards Metrics on Burnup Quantification and Plutonium Content in LWR SNF  

SciTech Connect

Globally, there exists a long history in reprocessing in evaluation of the shipper/receiver difference (SRD) on spent nuclear fuel (SNF) received and processed. Typically, the declared shipper s values for uranium and plutonium in SNF (based on calculations involving the initial manufacturer s data and reactor operating history) are used as the input quantities to the head-end process of the facility. Problems have been encountered when comparing these values with measured results of the input accountability tank contents. A typical comparison yields a systematic bias indicated as a loss of 5 7 percent of the plutonium (Pu) and approximately 1 percent for the uranium (U). Studies suggest that such deviation can be attributed to the non-linear nature of the axial burnup values of the SNF. Oak Ridge National Laboratory and Texas A&M University are co-investigating the development of a new method, via Nondestructive Assay (NDA) techniques, to improve the accuracy in burnup and Pu content quantification. Two major components have been identified to achieve this objective. The first component calculates a measurement-based burnup profile along the axis of a fuel rod. Gamma-ray data is collected at numerous locations along the axis of the fuel rod using a High Purity Germanium (HPGe) detector designed for a wide range of gamma-ray energies. Using two fission products, 137Cs and 134Cs, the burnup is calculated at each measurement location and a profile created along the axis of the rod based on the individual measurement locations. The second component measures the U/Pu ratio using an HPGe detector configured for relatively low-energy gamma-rays including x-rays. Fluorescence x-rays from U and Pu are measured and compared to the U/Pu ratio determined from a destructive analysis of the sample. This will be used to establish a relationship between the measured and actual values. This relationship will be combined with the burnup analysis results to establish a relationship between fission product activity and Pu content. It is anticipated that this new method will allow receiving facilities to make a limited number of NDA, gamma-ray, measurements to confirm the shipper declared values for burnup and Pu content thereby improving the SRD.

Saavedra, Steven F [ORNL; Charlton, William S [Texas A& M University; Solodov, Alexander A [ORNL; Ehinger, Michael H [ORNL

2010-01-01

166

Patients’ Understanding of the Regulation of Dietary Supplements  

Microsoft Academic Search

The Dietary Supplement Health and Education Act (DSHEA) permits manufacturers to sell products without providing pre-market\\u000a evidence of safety or efficacy. One fundamental reason for the passage of the DSHEA was to empower consumers to make their\\u000a own choices, free from governmental restriction. Yet, little is known about the public’s understanding of the supplement regulatory\\u000a process. We undertook a study

Bimal H. Ashar; Redonda G. Miller; Carmen P. Pichard; Rachel Levine; Scott M. Wright

2008-01-01

167

Intercollegiate student athlete use of nutritional supplements and the role of athletic trainers and dietitians in nutrition counseling  

Microsoft Academic Search

A survey of university student athletes was conducted to determine supplement use, perceived efficacy of supplements, availability and use of nutrition services, and perceived nutrition knowledge of athletic trainers. Results from 236 athletes showed that 88% used one or more nutritional supplements, yet perceived efficacy was moderate (2.9 or less; 5-point scale). Classes (69.4%), brochures (75%), and individual counseling (47%)

Robert D. Burns; M. Rosita Schiller; Mark A. Merrick; Kay N. Wolf

2004-01-01

168

Calcium supplements: Practical considerations  

Microsoft Academic Search

The preferable source of calcium is a balanced diet, but medicinal supplements are sometimes necessary if patients are to reach desired intakes. A divided dose regimen (4×\\/d; i.e., with meals and at bedtime) results in substantially greater absorption of a supplement than does l×\\/d dosing. However, differences in chemical solubility between supplement preparations are of little importance, with calcium carbonate

R. P. Heaney

1991-01-01

169

Remote-controlled NDA (nondestructive assay) systems for process areas in a MOX (mixed oxide) facility  

SciTech Connect

Nondestructive assay (NDA) systems have been designed and installed in the process area of an automated mixed-oxide (MOX) fuel fabrication facility. These instruments employ neutron coincidence counting methods to measure the spontaneous-fission rate of plutonium in the powders, pellets, and fuel pins in the process area. The spontaneous fission rate and the plutonium isotopic ratios determine the mass of plutonium in the sample. Measurements can be either attended or unattended. The fuel-pin assay system (FPAS) resides above the robotic conveyor system and measures the plutonium content in fuel-pin trays containing up to 24 pins (/approximately/1 kg of plutonium). The material accountancy glove-box (MAGB) counters consist of two slab detectors mounted on the sides of the glove box to measure samples of powder or pellets as they are brought to the load cell. Samples measured by the MAGB counters may contain up to 18 kg of MOX. This paper describes the design and performance of four systems: the fuel-pin assay system and three separate MAGB systems. The paper also discusses the role of Monte Carlo transport techniques in the detector design and subsequent instrument calibration. 5 refs., 11 figs., 6 tabs.

Miller, M.C.; Menlove, H.O.; Augustson, R.H.; Ohtani, T.; Seya, M.; Takahashi, S.; Abedin-Zadeh, R.

1989-01-01

170

The use of TI-208 gamma rays for safeguards, nondestructive-assay (NDA) measurements  

SciTech Connect

This paper examines two cases where gamma rays from Tl-208, including the 2614keV gamma ray, were used to detect anomalies in waste material. In addition to the characterization of waste for waste acceptance, and compliance with environmental and transportation laws, there is a safeguards element as well. The more sophisticated method of NDA at Y-12 includes a means to detect shielded special nuclear material (SNM). Excess count rates in the 2614keV gamma ray from Tl-208 are an indication of potential shielded HEU in waste as well as other containers. The 2614keV gamma ray is easy to monitor routinely. When a large 2614keV peak is detected, further investigation can be conducted from the gamma spectrum. This paper describes this further investigation in two cases. In one case self-shielded HEU was detected. In the other case the Tl-208 gamma rays came from a piece of Th-232 metal.

Oberer, R. B.; Chiang, L. G.; Norris, M. J.; Gunn, C. A.; Adaline, B. C.

2009-05-26

171

NDA measurement of the enrichment of uranium in the product header pipes in the cascade area  

SciTech Connect

The gamma rays measurements on product header pipes inside the cascade areas in a gas centrifuge enrichment plant have been performed with a high resolution Ge detector. The purpose of the present work is to investigate whether the NDA measurement can verify the declared enrichment level or not. The uranium deposit can be estimated from the difference in count rate of 185.7 keV gamma rays between with and without uranium gas in the product pipes. It was found that the amounts of deposit were less than those of gas phase uranium. 185.7 keV, 84.2 keV and 63.3 keV gamma rays intensities were measured to determine the enrichment. The obtained results of the count rate of 185.7 keV gamma rays were almost constant over several months. This means that the gas pressure is stable and the increasing rate of the uranium deposit is small enough. The measurement time required was at most 10 minutes. So the authors can conclude that the measurement of 185.7 keV gamma rays intensity gives quick indication of the no production of uranium higher than declared enrichment under the condition that the pressure of UF/sub 6/ gas is constant. The measurement of the 84.2 keV and 63.3 keV gamma rays intensity would also be effective measures in determining the enrichment of UF/sub 6/ gas.

Yokota, S.; Hori, M.; Iwamoto, T.; Akiba, M.; Omae, M.

1985-01-01

172

Fatty Acid and Phytosterol Content of Commercial Saw Palmetto Supplements  

PubMed Central

Saw palmetto supplements are one of the most commonly consumed supplements by men with prostate cancer and/or benign prostatic hyperplasia (BPH). Some studies have found significant improvements in BPH and lower urinary tract symptoms (LUTS) with saw palmetto supplementation, whereas others found no benefits. The variation in the efficacy in these trials may be a result of differences in the putative active components, fatty acids and phytosterols, of the saw palmetto supplements. To this end, we quantified the major fatty acids (laurate, myristate, palmitate, stearate, oleate, linoleate) and phytosterols (campesterol, stigmasterol, ?-sitosterol) in 20 commercially available saw palmetto supplements using GC-FID and GC-MS, respectively. Samples were classified into liquids, powders, dried berries, and tinctures. Liquid saw palmetto supplements contained significantly higher (p < 0.05) concentrations of total fatty acids (908.5 mg/g), individual fatty acids, total phytosterols (2.04 mg/g), and individual phytosterols, than the other supplement categories. Powders contained significantly higher (p < 0.05) concentrations of total fatty acids than tinctures, which contain negligible amounts of fatty acids (46.3 mg/g) and phytosterols (0.10 mg/g). Our findings suggest that liquid saw palmetto supplements may be the best choice for individuals who want to take a saw palmetto supplement with the highest concentrations of both fatty acids and phytosterols.

Penugonda, Kavitha; Lindshield, Brian L.

2013-01-01

173

Should supplemental antioxidant administration be avoided during chemotherapy and radiation therapy?  

Technology Transfer Automated Retrieval System (TEKTRAN)

Despite nearly two decades of research investigating the use of dietary antioxidant supplementation during conventional chemotherapy and radiation therapy, controversy remains about the efficacy and safety of this complementary treatment. Several studies of concurrent antioxidant administration with...

174

NASA Thesaurus Supplement.  

National Technical Information Service (NTIS)

The NASA Thesaurus Supplement is a cumulative update to the 1998 edition of the NASA Thesaurus (NASA/SP-1998-7501). The Supplement, published every six months, includes all new terms and associated hierarchies added since the cutoff for the 1998 edition (...

1999-01-01

175

Determinants of supplement usage  

Microsoft Academic Search

Background: As the use of supplements is growing, this study examines the determinants of vitamin and herbal supplement usage. Instead of treating these as all-encompassing categories, they are broken into specific vitamins and herbs and compared to see if users are different. A measure of frequency of vitamin use is also created.Methods: Logistic and ordinal logistic regressions are run on

Dana Fennell

2004-01-01

176

Calcium supplementation: cardiovascular risk?  

PubMed

Adequate dietary calcium intake and appropriate sunlight exposure ensuring adequate vitamin D availability are basic measures for the prevention of osteoporosis. Calcium and vitamin D supplementation increases bone density. Vitamin D plus calcium supplementation prevents hip fractures and other nonvertebral fractures in institutionalised persons 70 years of age or older. A meta-analysis of clinical trials showed an increase in myocardial infarction in patients taking calcium supplementation alone, with a relative risk of about 1.3. Epidemiological studies have not shown an increase in the cardiovascular risk. Conflicting results have also been reported in postmenopausal women taking both calcium and vitamin D. In an epidemiological study, hypercalcaemia was associated with increased mortality, particularly cardiovascular mortality. In practice, caution dictates that not all patients should routinely take calcium and vitamin D supplements. When calcium supplements are nonetheless used, the dose should be adjusted to dietary intake in order to avoid hypercalcaemia. PMID:23866352

2013-06-01

177

Herbs, Supplements and Alternative Medicines  

MedlinePLUS

... Treatment & Care > Medication > Herbs, Supplements, and Alternative Medicines Herbs, Supplements and Alternative Medicines Listen Today, more and ... adapted from The American Diabetes Association Guide to Herbs & Nutritional Supplements , written by Laura Shane-McWhorter, PharmD, ...

178

Effects of Coleus Forskohlii Supplementation on Body Composition and Hematological Profiles in Mildly Overweight Women  

Microsoft Academic Search

PURPOSE: This study investigated the effects of Coleus Forskohlii (CF) on body composition, and determined the safety and efficacy of supplementation. METHODS: In a double blind and randomized manner, 23 females supplemented their diet with ForsLean™ (250 mg of 10% CF extract, (n = 7) or a placebo [P] (n = 12) two times per day for 12-wks. Body composition

Shonteh Henderson; Bahrat Magu; Chris Rasmussen; Stacey Lancaster; Chad Kerksick; Penny Smith; Charlie Melton; Patty Cowan; Mike Greenwood; Conrad Earnest; Anthony Almada; Pervis Milnor; Terri Magrans; Rodney Bowden; Song Ounpraseuth; Ashli Thomas; Richard B. Kreider

2005-01-01

179

Does a liquid supplement improve energy and protein consumption in nursing home residents?  

Microsoft Academic Search

One popular strategy to improve the acceptance and efficacy of oral liquid supplements in long-term care is dispensing them during the medication pass, although few studies support its effectiveness. This study evaluated the impact of a supplement medication pass program on energy and nutrient consumption and weight in nursing home residents. Findings indicate that residents maintained their prestudy weight and

Robin E. Remsburg; Terri Sobel; Ashli Cohen; Cheryl Koch; Charlotte Radu

2001-01-01

180

Use of Nonprescription Dietary Supplements for Weight Loss Is Common among Americans  

Microsoft Academic Search

ObjectiveDietary supplements are not recommended as part of a weight-loss program due to concerns about efficacy and safety. This study sought to assess prevalence and duration of nonprescription weight-loss supplement use, associated weight-control behaviors, discussion of use with a health care professional, and specific ingredient use.

Heidi Michels Blanck; Mary K. Serdula; Cathleen Gillespie; Deborah A. Galuska; Patricia A. Sharpe; Joan M. Conway; Laura Kettel Khan; Barbara E. Ainsworth

2007-01-01

181

Micronutrient supplementation and its relationship to nutritional status, health and diseases  

Microsoft Academic Search

Micronutrient deficiency is still a major problem in many developing countries and multiple micronutrient deficiencies often occur concomitantly. Micronutrient supplementation may be the preferred option because it is cost-effective. Supplementation with iodized peanut oil was more efficacious and gave a longer protection period in preventing iodine deficiency than did iodized poppy seed oil. Inclusion of vitamin A in the iron

Juliawati Untoro; Siti Muslimatun; Elvina Karyadi

2002-01-01

182

The Effect of L-Carnitine Supplementation on Lean Body Mass in Male Amateur Body Builders  

Microsoft Academic Search

LEARNING OUTCOME:To assess the efficacy of L-carnitine supplementation on lean body mass in male body buildersIt has been hypothesized that since L-carnitine is involved in the transport of fatty acids across the mitochondrial membrane, supplementation might enhance fatty acid oxidation and thereby improve endurance and performance allowing for a greater training effect. This study examined the effect of L-carnitine supplementation

R. E. Green; A. M. Levine; M. J. Gunning; L. S. Walsh

1997-01-01

183

AN NDA Technique for the Disposition of Mixed Low Level Waste at the Advanced Mixed Waste Treatment Project  

SciTech Connect

The AMWTP is aggressively characterizing and shipping transuranic (TRU) waste to meet the DOE-IDs goal of 6000m3 of TRU waste to the Waste Isolation Pilot Plant (WIPP). The AMWTP shipping schedule requires streamlined waste movements and efficient waste characterization. Achieving this goal is complicated by the presence of waste that cannot be shipped to WIPP. A large amount of this waste is non-shippable due to the fact that no measurable TRU activity is identified during non-destructive assay (NDA).

M.J. Clapham; J.V. Seamans; R.E. Arbon

2006-05-16

184

Endometrium Kanseri Olgular›nda Laparatomi ve Robotik Asiste Laparoskopi Sonuçlar›n›n Karfl›laflt›r›lmas  

Microsoft Academic Search

ÖZET Endometrium kanseri olgular›nda laparatomi ve robotik asiste laparoskopi sonuçlar›n›n karfl›laflt›r›lmas› Endometrium kanseri evrelendirmesinde robotik asiste laparoskopik cerrahi ile laparotomi sonuçlar›n›n karfl›laflt›r›lmas› Amaçlar: Endometrium kanseri nedeniyle robotik asiste laparoskopik cerrahi ve laparotomi ile evrelendirme yap›lan hastalar›n sonuçlar›n› kar- fl›laflt›rmak. Gereç ve Yöntem: Çal›flmaya robotik asiste endometrial staging yap›lan 6 hasta (grup 1) ile aç›k cerrahi evrelendirme yap›lan 12 hasta (grup

Ahmet Göçmen; Mustafa Uçar

2009-01-01

185

administrative_supplement_target  

Cancer.gov

NCI Guidelines for Administrative Supplements in Support of Expanding the Childhood Cancer TARGET Initiative Title: Childhood Cancer TARGET Initiative Expansion – Tissue Collections and Characterization Announcement Number: NOT-OD-09-056 NIH Announces

186

Breastfeeding: Vitamin D Supplementation  

MedlinePLUS

... able to synthesize additional vitamin D through routine sunlight exposure. However, published reports of cases of vitamin ... a vitamin supplement or from adequate exposure to sunlight. A number of factors decrease the amount of ...

187

Dietary Supplement Labeling Guide  

Center for Food Safety and Applied Nutrition (CFSAN)

... The Dietary Supplement Health and Education Act of ... These regulations also required the unit-dose ... we published a final regulation that amended ... More results from www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation

188

Children and Dietary Supplements  

MedlinePLUS

... Dietary Supplements and Nutraceuticals (Endocrine Practice) [945KB PDF] Probiotics and Children (Journal of Pediatric Gastroenterology and Nutrition) [ ... Two Studies Explore the Potential Health Benefits of Probiotics (07/04/08) Traditional Chinese Herbs May Benefit ...

189

Who Needs Supplements?  

MedlinePLUS

... are getting adequate intake of necessary vitamins and minerals. To avoid indigestion, take the multivitamin with food. ... menstruation may need to take a multivitamin and mineral supplement that contains iron to meet the daily ...

190

Habituation: Supplemental Bibliography.  

National Technical Information Service (NTIS)

The bibliographic survey of habituation literature compiled earlier by the author (Psychonomic Monograph Supplements, 1972, 4, 189-217) is updated. Eight-hundred and fifty references to articles dealing with habituatory phenomena, two-thirds of which have...

B. C. Leibrecht

1973-01-01

191

DMAA in Dietary Supplements  

Center for Food Safety and Applied Nutrition (CFSAN)

... are illegal and FDA is doing everything within its ... How does FDA regulate ingredients in dietary ... Unlike drugs, dietary supplements do not have pre ... More results from www.fda.gov/food/dietarysupplements/qadietarysupplements

192

Supplements to Textbook Materials.  

ERIC Educational Resources Information Center

|Describes the many kinds of materials that English teachers can draw upon to enrich and expand students' experiences with literature. Outlines ancillary materials used to supplement the study of William Shakespeare's "Julius Caesar." (HB)|

Holmes, Ken

1994-01-01

193

ADHD and nutritional supplements  

Microsoft Academic Search

Many children with attention-deficit\\/hyperactivity disorder (ADHD) use nutritional therapies (supplements and elimination\\u000a diets) as a treatment strategy. This article reviews the use of supplements in ADHD. Several nutrients have known roles in\\u000a the support of brain function. Nutrient sufficiency during brain development is critical. Because 1) data indicate that many\\u000a American schoolchildren do not meet nutritional recommendations, 2) the prefrontal

Marianne M. Glanzman

2009-01-01

194

Meta-analysis of Long-Chain Polyunsaturated Fatty Acid Supplementation of Formula and Infant Cognition  

PubMed Central

BACKGROUND AND OBJECTIVE: Infant formula is supplemented with long-chain polyunsaturated fatty acids (LCPUFAs) because they are hypothesized to improve cognition. Several randomized controlled clinical trials have examined the effect of LCPUFA supplementation of infant formula on cognitive development. We conducted this meta-analysis to examine the efficacy of LCPUFA supplementation of infant formula on early cognitive development. METHODS: Two authors searched PubMed, PsychInfo, and Scopus for randomized controlled clinical trials assessing the efficacy of LCPUFA supplementation of infant formulas on cognition. Our analysis was restricted to randomized controlled clinical trials that examined the effect of LCPUFA supplementation on infant cognition using Bayley Scales of Infant Development. Our primary outcome was the weighted mean difference in Bayley Scales of Infant Development score between infants fed formula supplemented with LCPUFA compared with unsupplemented formula. We conducted secondary subgroup analyses and meta-regression to examine the effects of study sample, LCPUFA dose, and trial methodologic quality on measured efficacy of supplementation. RESULTS: Twelve trials involving 1802 infants met our inclusion criteria. Our meta-analysis demonstrated no significant effect of LCPUFA supplementation of formula on infant cognition. There was no significant heterogeneity or publication bias between trials. Secondary analysis failed to show any significant effect of LCPUFA dosing or prematurity status on supplementation efficacy. CONCLUSIONS: LCPUFA supplementation of infant formulas failed to show any significant effect on improving early infant cognition. Further research is needed to determine if LCPUFA supplementation of infant formula has benefits for later cognitive development or other measures of neurodevelopment.

Qawasmi, Ahmad; Landeros-Weisenberger, Angeli; Leckman, James F.

2012-01-01

195

Dietary supplement increases plasma norepinephrine, lipolysis, and metabolic rate in resistance trained men  

Microsoft Academic Search

BACKGROUND: Dietary supplements targeting fat loss and increased thermogenesis are prevalent within the sport nutrition\\/weight loss market. While some isolated ingredients have been reported to be efficacious when used at high dosages, in particular in animal models and\\/or via intravenous delivery, little objective evidence is available pertaining to the efficacy of a finished product taken by human subjects in oral

Richard J Bloomer; Kelsey H Fisher-Wellman; Kelley G Hammond; Brian K Schilling; Adrianna A Weber; Bradford J Cole

2009-01-01

196

Effect of four-day psyllium supplementation on bowel preparation for colonoscopy:A prospective double blind randomized trial [ISRCTN76623768  

Microsoft Academic Search

BACKGROUND: Patients with new onset constipation or presumed hemorrhoid bleeding frequently require the use of both fiber supplements and diagnostic colonoscopy. We sought to determine whether preliminary fiber supplementation would alter the tolerability or efficacy of a standard bowel preparation for colonoscopy METHODS: A prospective, double blind, randomized trial was designed to compare a short course of a psyllium-based supplement

Walter A Salwen; Marc D Basson

2004-01-01

197

DOES IT WORK? TESTING THE EFFICACY OF FEED SUPPLEMENTS  

Microsoft Academic Search

Advancements in equine nutrition have boomed in the last several years. In the past, nutritional research focused on the nutritional content and availability of various feedstuffs with an eye on providing a balanced ration to meet the energy and nutrient needs of the equine athlete. More recent research has followed the example of human sports nutrition and has examined the

KENNETH H. MCKEEVER

198

Multinutrient supplement containing ephedra and caffeine causes weight loss and improves metabolic risk factors in obese women: a randomized controlled trial  

Microsoft Academic Search

Objective:To determine the safety and efficacy of a dietary supplement with a low dose of ephedra and caffeine in overweight\\/obese premenopausal female subjects.Design:A 9-month, double-blind, randomized control study compared the efficacy and safety of a dietary supplement with ephedra and caffeine to a control supplement.Subjects:Sixty-one healthy, premenopausal women with body mass index (BMI) from 27 to 39 kg\\/m2 were randomly

R M Hackman; P J Havel; H J Schwartz; J C Rutledge; M R Watnik; E M Noceti; S J Stohs; J S Stern; C L Keen

2006-01-01

199

Performance enhancement with supplements: incongruence between rationale and practice  

PubMed Central

Background Athletes are expected to consider multiple factors when making informed decision about nutritional supplement use. Besides rules, regulations and potential health hazards, the efficacy of different nutritional supplements in performance enhancement is a key issue. The aim of this paper was to find evidence for informed decision making by investigating the relationship between specific performance-related reasons for supplement use and the reported use of nutritional supplements. Methods The 'UK Sport 2005 Drug Free Survey' data (n = 874) were re-analysed using association [?2] and 'strength of association' tests [?] to show the proportion of informed choices and to unveil incongruencies between self-reported supplement use and the underlying motives. Results Participants (n = 520) reported supplement use in the pattern of: vitamin C (70.4%), creatine (36.1%), whey protein (30.6%), iron (29.8%), caffeine (23.8%), and ginseng (8.3%) for the following reasons: strength maintenance (38.1%), doctors' advice (24.2%), enhancing endurance (20.0%), ability to train longer (13.3%), and provided by the governing body (3.8%). Of thirty possible associations between the above supplements and reasons, 11 were predictable from literature precedents and only 8 were evidenced and these were not strong (? < .7). The best associations were for the ability to train longer with creatine (reported by 73.9%, ?2 = 49.14, p < .001; ? = .307, p < .001), and maintaining strength with creatine (reported by 62.6%, ?2 = 97.08, p < .001; ? = .432, p < .001) and whey protein (reported by 56.1%, ?2 = 97.82, p < .001; ? = .434, p < .001). Conclusion This study provided a platform for assessing congruence between athletes' reasons for supplement use and their actual use. These results suggest that a lack of understanding exists in supplement use. There is an urgent need to provide accurate information which will help athletes make informed choices about the use of supplements.

Petroczi, Andrea; Naughton, Declan P; Mazanov, Jason; Holloway, Allison; Bingham, Jerry

2007-01-01

200

Dietary supplements for athletes: emerging trends and recurring themes.  

PubMed

Dietary supplements are widely used at all levels of sport. Changes in patterns of supplement use are taking place against a background of changes in the regulatory framework that governs the manufacture and distribution of supplements in the major markets. Market regulation is complicated by the increasing popularity of Internet sales. The need for quality control of products to ensure they contain the listed ingredients in the stated amount and to ensure the absence of potentially harmful substances is recognized. This latter category includes compounds prohibited under anti-doping regulations. Several certification programmes now provide testing facilities for manufacturers of both raw ingredients and end products to ensure the absence of prohibited substances. Athletes should carry out a cost-benefit analysis for any supplement they propose to use. For most supplements, the evidence is weak, or even completely absent. A few supplements, including caffeine, creatine, and bicarbonate, are supported by a strong research base. Difficulties arise when new evidence appears to support novel supplements: in recent years, ?-alanine has become popular, and the use of nitrate and arginine is growing. Athletes seldom wait until there is convincing evidence of efficacy or of safety, but caution is necessary to minimize risk. PMID:22150428

Maughan, R J; Greenhaff, P L; Hespel, P

2011-01-01

201

Supplements and sports.  

PubMed

Use of performance-enhancing supplements occurs at all levels of sports, from professional athletes to junior high school students. Although some supplements do enhance athletic performance, many have no proven benefits and have serious adverse effects. Anabolic steroids and ephedrine have life-threatening adverse effects and are prohibited by the International Olympic Committee and the National Collegiate Athletic Association for use in competition. Blood transfusions, androstenedione, and dehydroepiandrosterone are also prohibited in competition. Caffeine, creatine, and sodium bicarbonate have been shown to enhance performance in certain contexts and have few adverse effects. No performance benefit has been shown with amino acids, beta-hydroxy-beta-methylbutyrate, chromium, human growth hormone, and iron. Carbohydrate-electrolyte beverages have no serious adverse effects and can aid performance when used for fluid replacement. Given the widespread use of performance-enhancing supplements, physicians should be prepared to counsel athletes of all ages about their effectiveness, safety, and legality. PMID:19007050

Jenkinson, David M; Harbert, Allison J

2008-11-01

202

NASA (National Aeronautics and Space Administration) Thesaurus Supplement. Supplement 3.  

National Technical Information Service (NTIS)

The four part cumulative NASA Thesaurus Supplement to the 1985 edition of the NASA Thesaurus includes Part 1, Hierarchical Listing, Part 2, Access Vocabulary, Part 3, NASA Thesaurus Definitions, and Part 4, Changes. The semiannual supplement gives complet...

1987-01-01

203

Supplement use by Young Athletes  

PubMed Central

This paper reviews studies of supplement use among child and adolescent athletes, focusing on prevalence and type of supplement use, as well as gender comparisons. Supplement use among adult athletes has been well documented however there are a limited number of studies investigating supplement use by child and adolescent athletes. A trend in the current literature revealed that the most frequently used supplements are in the form of vitamin and minerals. While health and illness prevention are the main reasons for taking supplements, enhanced athletic performance was also reported as a strong motivating factor. Generally, females are found to use supplements more frequently and are associated with reasons of health, recovery, and replacing an inadequate diet. Males are more likely to report taking supplements for enhanced performance. Both genders equally rated increased energy as another reason for engaging in supplement use. Many dietary supplements are highly accessible to young athletes and they are particularly vulnerable to pressures from the media and the prospect of playing sport at increasingly elite levels. Future research should provide more direct evidence regarding any physiological side effects of taking supplements, as well as the exact vitamin and mineral requirements for child and adolescent athletes. Increased education for young athletes regarding supplement use, parents and coaches should to be targeted to help the athletes make the appropriate choices. Key pointsSupplement use among the child and adolescent athlete population is widespread with the most frequently used supplement being a form of vitamin/mineral supplement.The effects of supplement use on the growth and development of children and adolescents remain unclear and thus use of supplements by this population should be discouraged.It is likely that there is a misunderstanding as to the role of vitamins and minerals in the diet, their function in maintaining overall health, their role in athletic performance, and how they are best obtained from the diet therefore further education for adolescent athletes and athletes in general is needed.

McDowall, Jill Anne

2007-01-01

204

Combat Ocular Problems. Supplement.  

National Technical Information Service (NTIS)

This report is a supplement to Proceedings of Conference conducted October 20-21, 1980. Contents include: (1) Ocular Effects of Relatively 'Eye Safe' Lasers; (2) Bioeffects Concerning the Safe Use of GaAs Laser Training Devices; (3) Laser Flash Effects; (...

E. S. Beatrice

1982-01-01

205

Speechreading with Tactile Supplements.  

ERIC Educational Resources Information Center

|Reviewed is the historical development of tactile aids to supplement speechreading by hearing-impaired individuals, from early use of bone conduction vibrators driven by hearing aids, to multichannel tactile aids representing the full speech spectrum and tactile speechreading aids complementing visual cues. Adequate training in use of tactile…

Plant, Geoff

1988-01-01

206

Ethnic Heritage: Supplemental Readings.  

ERIC Educational Resources Information Center

|These supplemental readings are part of a total packet of learning materials on the heritage of Southern agrarians. The readings are prefaced by a story of Southern life told in pictures. The primary source readings cover the following topics: (1) Farmers Unions, (2) Farm Tenancy, (3) Recovery Programs of the Roosevelt Administration, (4) Cotton…

Powell, Roberta

207

Weight Loss Nutritional Supplements  

Microsoft Academic Search

Obesity has reached what may be considered epidemic proportions in the United States, not only for adults but for children. Because of the medical implications and health care costs associated with obesity, as well as the negative social and psychological impacts, many individuals turn to nonprescription nutritional weight loss supplements hoping for a quick fix, and the weight loss industry

Joan M. Eckerson

2008-01-01

208

Psychology: Teacher Supplement.  

ERIC Educational Resources Information Center

|This supplement provides teachers with tests, quizzes, answers to questions in the text, and general teaching information for using the student text, "Psychology," by Rebecca Stark. Quizzes included are on the topics of human development; the nervous system; the brain; cognitive development; sensation and perception; conditioning; learning;…

Stark, Rebecca

209

Supplements containing banned substances  

Microsoft Academic Search

Over the past years, NMI has been monitoring and determining compounds contained in so called ‘supplements’, which are or can be classified as banned within the definitions of the WADA Prohibited List. The items studied have been chosen for investigation because the advertised content declarations show that major ingredients may fall into this banned category. It is clear that many

Rymantas Kazlauskas

2010-01-01

210

Premarket Approval (PMA) Manual Supplement.  

National Technical Information Service (NTIS)

The publication is a supplement to the 'Premarket Approval (PMA) Manual' that describes the required arrangement and content of a premarket approval application (PMA). The purpose of the supplement is to provide additional PMA guidance and policy that has...

N. Lowe

1991-01-01

211

Vitamin Supplements: Healthy or Hoax?  

MedlinePLUS

... Hoax? Updated:Jun 20,2013 Can vitamin and mineral supplements really make you healthier? Overwhelmed by the towering shelves of vitamin and mineral supplements in the grocery store? There are so ...

212

Should You Take Dietary Supplements?  

MedlinePLUS

... You Take Dietary Supplements? A Look at Vitamins, Minerals, Botanicals and More When you reach for that ... powder or liquid form. Common supplements include vitamins, minerals and herbal products, also known as botanicals. People ...

213

Weekly iron supplementation is as effective as 5 day per week iron supplementation in Bolivian school children living at high altitude  

Microsoft Academic Search

Objective: To compare the efficacy of a daily and a weekly iron supplementation on the hematological status of anemic children living at high altitude. Design: Double blind iron supplementation trial including a placebo control group. Setting: A socioeconomically disadvantaged district of La Paz, Bolivia (altitude of 4000 m). Subjects: Anemic (hemoglobin concentration?144 g\\/L), 3.3–8.3 y old children of both sexes.

J Berger; VM Aguayo; W Téllez; C Luján; P Traissac; JL San Miguel

1997-01-01

214

An Evidence-Based Review of Fat Modifying Supplemental Weight Loss Products  

PubMed Central

Objective. To review the literature on fat modifying dietary supplements commonly used for weight loss. Methods. Recently published randomized, placebo-controlled trials were identified in PubMed, MEDLINE, International Pharmaceutical Abstracts, Cochrane Database, and Google Scholar using the search terms dietary supplement, herbal, weight loss, obesity, and individual supplement names. Discussion. Data for conjugated linoleic acid (CLA), Garcinia cambogia, chitosan, pyruvate, Irvingia gabonensis, and chia seed for weight loss were identified. CLA, chitosan, pyruvate, and Irvingia gabonensis appeared to be effective in weight loss via fat modifying mechanisms. However, the data on the use of these products is limited. Conclusion. Many obese people use dietary supplements for weight loss. To date, there is little clinical evidence to support their use. More data is necessary to determine the efficacy and safety of these supplements. Healthcare providers should assist patients in weighing the risks and benefits of dietary supplement use for weight loss.

Egras, Amy M.; Hamilton, William R.; Lenz, Thomas L.; Monaghan, Michael S.

2011-01-01

215

An evidence-based review of fat modifying supplemental weight loss products.  

PubMed

Objective. To review the literature on fat modifying dietary supplements commonly used for weight loss. Methods. Recently published randomized, placebo-controlled trials were identified in PubMed, MEDLINE, International Pharmaceutical Abstracts, Cochrane Database, and Google Scholar using the search terms dietary supplement, herbal, weight loss, obesity, and individual supplement names. Discussion. Data for conjugated linoleic acid (CLA), Garcinia cambogia, chitosan, pyruvate, Irvingia gabonensis, and chia seed for weight loss were identified. CLA, chitosan, pyruvate, and Irvingia gabonensis appeared to be effective in weight loss via fat modifying mechanisms. However, the data on the use of these products is limited. Conclusion. Many obese people use dietary supplements for weight loss. To date, there is little clinical evidence to support their use. More data is necessary to determine the efficacy and safety of these supplements. Healthcare providers should assist patients in weighing the risks and benefits of dietary supplement use for weight loss. PMID:20847896

Egras, Amy M; Hamilton, William R; Lenz, Thomas L; Monaghan, Michael S

2010-08-10

216

Supplement use by young athletes  

Microsoft Academic Search

This paper reviews studies of supplement use among child and adolescent athletes, focusing on prevalence and type of supple- ment use, as well as gender comparisons. Supplement use among adult athletes has been well documented however there are a limited number of studies investigating supplement use by child and adolescent athletes. A trend in the current literature revealed that the

Jill Anne McDowall

217

Effect of a short term dietary supplement combination program on weight management, adipose tissue, cholesterol and triglycerides in overweight adults  

Microsoft Academic Search

A dietary supplement combination program consisting of liquid supplement (PHASE DIETS LIQUID NUTRIENT CONCENTRATE) and a protein shake was studied to determine its safety and efficacy on weight\\/fat loss, cholesterol and triglycerides levels in thirty five overweight adults between ages 14-60. This open label trail measured total body weight, body fat percent- age, waist circumference, hips (females), chest (females), abdomen

Michael J. Gonzalez; Jorge R. Miranda-Massari; Carlos M. Ricart; Heidi Ortega; Saisha M. Muñiz Alers

218

A clinical trial of glutathione supplementation in autism spectrum disorders  

PubMed Central

Summary Background Recent evidence shows that subjects diagnosed with an autism spectrum disorder (ASD) have significantly lower levels of glutathione than typically developing children. The purpose of this study was to examine the use of two commonly used glutathione supplements in subjects diagnosed with an ASD to determine their efficacy in increasing blood glutathione levels in subjects diagnosed with an ASD. Material/Methods The study was an eight-week, open-label trial using oral lipoceutical glutathione (n=13) or transdermal glutathione (n=13) in children, 3–13 years of age, with a diagnosis of an ASD. Subjects underwent pre- and post-treatment lab testing to evaluate plasma reduced glutathione, oxidized glutathione, cysteine, taurine, free and total sulfate, and whole-blood glutathione levels. Results The oral treatment group showed significant increases in plasma reduced glutathione, but not whole-blood glutathione levels following supplementation. Both the oral and transdermal treatment groups showed significant increases in plasma sulfate, cysteine, and taurine following supplementation. Conclusions The results suggest that oral and transdermal glutathione supplementation may have some benefit in improving some of the transsulfuration metabolites. Future studies among subjects diagnosed with an ASD should further explore the pharmacokinetics of glutathione supplementation and evaluate the potential effects of glutathione supplementation upon clinical symptoms.

Kern, Janet K.; Geier, David A.; Adams, James B.; Garver, Carolyn R.; Audhya, Tapan; Geier, Mark R.

2011-01-01

219

Nutrition and nutritional supplementation  

PubMed Central

Skin acts as a natural barrier between internal and external environments thus plays an important role in vital biological functions such as protection against mechanical/chemical damages, micro-organisms, ultraviolet damage. Nutrition has a critical impact on strengthening skin’s capabilities to fight against these multiple aggressions. Nutritional deficiencies are often associated with skin health disorders, while diets can either positively or negatively influence skin condition. More recently, the concept of nutritional supplementation has emerged as a new strategy in the daily practice of dermatology as well as a complementary approach to topical cosmetics in the field of beauty. Focusing on human clinical data, this paper proposes to illustrate the link between skin health and nutrition and to exemplify the beneficial actions of nutritional supplementation in skin health and beauty.

Manissier, Patricia

2009-01-01

220

Effective Nutritional Supplement Combinations  

NASA Astrophysics Data System (ADS)

Few supplement combinations that are marketed to athletes are supported by scientific evidence of their effectiveness. Quite often, under the rigor of scientific investigation, the patented combination fails to provide any greater benefit than a group given the active (generic) ingredient. The focus of this chapter is supplement combinations and dosing strategies that are effective at promoting an acute physiological response that may improve/enhance exercise performance or influence chronic adaptations desired from training. In recent years, there has been a particular focus on two nutritional ergogenic aids—creatine monohydrate and protein/amino acids—in combination with specific nutrients in an effort to augment or add to their already established independent ergogenic effects. These combinations and others are discussed in this chapter.

Cooke, Matt; Cribb, Paul J.

221

Weight Loss Nutritional Supplements  

Microsoft Academic Search

\\u000a Obesity has reached what may be considered epidemic proportions in the United States, not only for adults but for children.\\u000a Because of the medical implications and health care costs associated with obesity, as well as the negative social and psychological\\u000a impacts, many individuals turn to nonprescription nutritional weight loss supplements hoping for a quick fix, and the weight\\u000a loss industry

Joan M. Eckerson

222

Use of dietary supplements for weight loss in the United States: results of a national survey.  

PubMed

We examined dietary supplement use for weight loss and perceptions about safety, efficacy, and regulatory oversight of these products. A random digit-dialed telephone survey was conducted in 2005-2006, with a representative sample of 3,500 US adults. The survey assessed the beliefs and practices related to weight control. Outcome measures included the prevalence of dietary supplement use for weight reduction, demographic profile of supplement users, and knowledge about safety, efficacy, and regulation of dietary supplements. Of the adults who made a serious weight-loss attempt (n = 1,444), 33.9% reported ever using a dietary supplement for weight loss. Supplement use was more common among women (44.9%) vs. men (19.8%); those aged 25-34; African Americans (48.7%) or Hispanics (41.6%) vs. whites (31.2%); less educated (38.4% high school degree or less vs. 31.1% some college or more); lower income households (41.8% made <$40K vs. 30.3% made > or =$40K); obese (40.7%) vs. overweight (29.1%); those who made more lifetime weight-loss attempts (42.0% made > or =3 vs. 22.1% made <3); and those who used more weight-loss methods (48.2% used > or =4 vs. 25.2% used <4). Many users and non-users of dietary supplements had misperceptions about these products-many believed they are evaluated for safety and efficacy by the Food and Drug Administration (FDA) before marketing, and that dietary supplements are safer than over-the-counter (OTC) or prescription medications. Use of dietary supplements for weight loss is common. More information about dietary supplements is necessary to correct misperceptions and encourage the use of safe and effective weight-loss methods. PMID:18239570

Pillitteri, Janine L; Shiffman, Saul; Rohay, Jeffrey M; Harkins, Andrea M; Burton, Steven L; Wadden, Thomas A

2008-01-24

223

Effect of betaine supplementation on power performance and fatigue  

Microsoft Academic Search

BACKGROUND: The purpose of this study was to examine the efficacy of 15 days of betaine supplementation on muscle endurance, power performance and rate of fatigue in active college-aged men. METHODS: Twenty-four male subjects were randomly assigned to one of two groups. The first group (BET; 20.4 ± 1.3 years; height: 176.8 ± 6.6 cm; body mass: 77.8 ± 13.4

Jay R Hoffman; Nicholas A Ratamess; Jie Kang; Stefanie L Rashti; Avery D Faigenbaum

2009-01-01

224

The challenges of iodine supplementation: a public health programme perspective.  

PubMed

An adequate iodine intake during pregnancy, lactation and early childhood is particularly critical for optimal brain development of the foetus and of children 7-24 months of age. While the primary strategy for sustainable elimination of iodine deficiency remains universal salt iodisation, the World Health Organization and the United Nations Children's Fund recommend a complementary strategy of iodine supplements as a temporary measure when salt iodisation could not be implemented. This article aims to review current evidence on efficacy and implications of implementing iodine supplementation as a public health measure to address iodine deficiency. Iodine supplementation seems unlikely to reach high coverage in a rapid, equitable and sustained way. Implementing the programme requires political commitment, effective and efficient supply, distribution and targeting, continuous education and communication and a robust monitoring system. Thus, universal salt iodisation should remain the primary strategy to eliminate iodine deficiency. PMID:20172473

Untoro, Juliawati; Timmer, Arnold; Schultink, Werner

2010-02-01

225

Leucine Supplementation Protects from Insulin Resistance by Regulating Adiposity Levels  

PubMed Central

Background Leucine supplementation might have therapeutic potential in preventing diet-induced obesity and improving insulin sensitivity. However, the underlying mechanisms are at present unclear. Additionally, it is unclear whether leucine supplementation might be equally efficacious once obesity has developed. Methodology/Principal Findings Male C57BL/6J mice were fed chow or a high-fat diet (HFD), supplemented or not with leucine for 17 weeks. Another group of HFD-fed mice (HFD-pairfat group) was food restricted in order to reach an adiposity level comparable to that of HFD-Leu mice. Finally, a third group of mice was exposed to HFD for 12 weeks before being chronically supplemented with leucine. Leucine supplementation in HFD-fed mice decreased body weight and fat mass by increasing energy expenditure, fatty acid oxidation and locomotor activity in vivo. The decreased adiposity in HFD-Leu mice was associated with increased expression of uncoupling protein 3 (UCP-3) in the brown adipose tissue, better insulin sensitivity, increased intestinal gluconeogenesis and preservation of islets of Langerhans histomorphology and function. HFD-pairfat mice had a comparable improvement in insulin sensitivity, without changes in islets physiology or intestinal gluconeogenesis. Remarkably, both HFD-Leu and HFD-pairfat mice had decreased hepatic lipid content, which likely helped improve insulin sensitivity. In contrast, when leucine was supplemented to already obese animals, no changes in body weight, body composition or glucose metabolism were observed. Conclusions/Significance These findings suggest that leucine improves insulin sensitivity in HFD-fed mice by primarily decreasing adiposity, rather than directly acting on peripheral target organs. However, beneficial effects of leucine on intestinal gluconeogenesis and islets of Langerhans's physiology might help prevent type 2 diabetes development. Differently, metabolic benefit of leucine supplementation is lacking in already obese animals, a phenomenon possibly related to the extent of the obesity before starting the supplementation.

Binder, Elke; Bermudez-Silva, Francisco J.; Andre, Caroline; Elie, Melissa; Romero-Zerbo, Silvana Y.; Leste-Lasserre, Thierry; Belluomo, llaria; Duchampt, Adeline; Clark, Samantha; Aubert, Agnes; Mezzullo, Marco; Fanelli, Flaminia; Pagotto, Uberto; Laye, Sophie; Mithieux, Gilles; Cota, Daniela

2013-01-01

226

The Efficacy, Safety, and Practicality of Treatments for Adolescents with Attention-Deficit\\/Hyperactivity Disorder (ADHD)  

Microsoft Academic Search

Studies examining interventions for adolescents diagnosed with attention-deficit\\/hyperactivity disorder (ADHD) were reviewed to evaluate their efficacy. These efficacy findings were supplemented with a preliminary system for judging safety and practicality. Results suggest that the stimulant drug methylphenidate (MPH) is safe and well-established empirically, but has some problems with inconvenience and noncompliance. Preliminary research supports the efficacy, safety, and practicality of

Bradley H. Smith; Daniel A. Waschbusch; Michael T. Willoughby; Steven Evans

2000-01-01

227

Preventing Paclitaxel-Induced Peripheral Neuropathy: A Phase II Trial of Vitamin E Supplementation  

Microsoft Academic Search

A randomized, controlled trial was performed to assess the efficacy and safety of vitamin E supplementation for prophylaxis against paclitaxel-induced peripheral neuropathy (PIPN). Thirty-two patients undergoing six courses of paclitaxel-based chemotherapy were randomly assigned to receive either chemotherapy with vitamin E (300mg twice a day, Group I) or chemotherapy without vitamin E supplementation (Group II). A detailed neurological examination and

Andreas A. Argyriou; Elisabeth Chroni; Angelos Koutras; Gregoris Iconomou; Spiridon Papapetropoulos; Panagiotis Polychronopoulos; Haralabos P. Kalofonos

2006-01-01

228

Use of Dietary Supplements for Weight Loss in the United States: Results of a National Survey  

Microsoft Academic Search

We examined dietary supplement use for weight loss and perceptions about safety, efficacy, and regulatory oversight of these products. A random digit-dialed telephone survey was conducted in 2005–2006, with a representative sample of 3,500 US adults. The survey assessed the beliefs and practices related to weight control. Outcome measures included the prevalence of dietary supplement use for weight reduction, demographic

Janine L. Pillitteri; Saul Shiffman; Jeffrey M. Rohay; Andrea M. Harkins; Steven L. Burton; Thomas A. Wadden

2008-01-01

229

Performance-enhancing supplements.  

PubMed

Supplements that are marketed as ergogenic aids have achieved widespread use in the United States. In image-conscious society, these agents are not only being consumed by athletes, but also by those looking for a quick fix to enhance their appearance. Many assume that the performance claims made by the manufacturers are based on actual data, and that these agents must be safe because they are sold to the general public. Unfortunately, in most cases these assumptions are false. Creatine has become very popular, particularly among college and high school athletes. Studies within the last 5 years have shown that creatine does seem to have certain ergogenic benefits in a laboratory setting. It is not currently known whether these benefits actually can be transferred to the playing field. Although creatine has not consistently been shown to cause any major side effects, there is some question regarding creatine's effect on the kidneys, particularly with long-term use. Also, the safety of supplementation in children and adolescents has not been examined at all; its use in this population should be discouraged until there are more data. Androstenedione is an agent that has received a large amount of popular press in the last year, and this has led to an surge in its usage. It is believed to exert its ergogenic effects through conversion to testosterone. But what limited data are available suggest that at the recommended dosage, it does not cause any measurable change in testosterone levels, or provide any ergogenic benefit in inexperienced weight lifters. Also, it has yet to be determined whether androstenedione causes any of the side effects often attributed to use of the illegal anabolic steroids. Its mechanism of action suggests it has the potential to cause many of these negative effects. Studies are just beginning to appear in the literature, and certainly more data need to be gathered before androstenedione supplementation can be recommended for use as an ergogenic aid. PMID:11092026

Pecci, M A; Lombardo, J A

2000-11-01

230

Nutritional Supplements for Endurance Athletes  

Microsoft Academic Search

\\u000a Athletes engaged in heavy endurance training often seek additional nutritional strategies to help maximize performance. Specific\\u000a nutritional supplements exist to combat certain factors that limit performance beginning with a sound everyday diet. Research\\u000a has further demonstrated that safe, effective, legal supplements are in fact available for today’s endurance athletes. Several\\u000a of these supplements are marketed not only to aid performance

Christopher J. Rasmussen

231

[Physical activity and dietary supplements].  

PubMed

The Danish Fitness and Nutrition Council has examined the scientific literature to evaluate the performance and health-related aspects of consuming dietary supplements in the context of physical activity. Certain nutritional supplements such as creatine and caffeine have documented ergogenic effects in specific situations. However, for the moderately physically active adult and healthy individual, who already consumes an energy- and nutrient balanced diet, consuming any currently legal dietary supplement does not seem to confer additional benefits on performance or health. PMID:19732518

Overgaard, Kristian; Hansen, Harald S; Hansen, Mette; Kiens, Bente; Kvorning, Thue; Nielsen, Lars N; Rasmussen, Lone B; Aagaard, Peter G

2009-08-17

232

Nutrient supplementation: improving male fertility fourfold.  

PubMed

Oxidative stress can contribute to impairment in spermatogenesis leading to male-factor infertility. The effectiveness of various antioxidants (such as carnitine, vitamin C, vitamin E, selenium, carotenoids, glutathione, N-acetylcysteine, zinc, folic acid, and coenzyme Q10) is variable with respect to improving semen parameters and pregnancy rates. A recent Cochrane review determined that men taking antioxidants had a statistically significant increase in both live birth rates and pregnancy rates. For those undergoing assisted reproduction, the odds ratio that antioxidant use would improve pregnancy rates was 4.18, with a 4.85-fold improvement in live birth rate also noted. Further investigation with randomized, controlled clinical trials is needed to confirm the safety and efficacy of antioxidant supplementation in the medical management and treatment of male infertility. PMID:23775385

Mora-Esteves, Cesar; Shin, David

2013-06-17

233

Consumer Research on Dietary Supplements  

Center for Food Safety and Applied Nutrition (CFSAN)

... Trends in Prevalence and Magnitude of Vitamin and Mineral Supplement Usage and Correlation with Health Status. 1992. ... More results from www.fda.gov/food/foodscienceresearch/consumerbehaviorresearch

234

Development of an NDA system for high-level waste from the Chernobyl new safe confinement construction site  

SciTech Connect

In early 2009, preliminary excavation work has begun in preparation for the construction of the New Safe Confinement (NSC) at the Chernobyl Nuclear Power Plant (ChNPP) in Ukraine. The NSC is the structure that will replace the present containment structure and will confine the radioactive remains of the ChNPP Unit-4 reactor for the next 100 years. It is expected that special nuclear material (SNM) that was ejected from the Unit-4 reactor during the accident in 1986 could be uncovered and would therefore need to be safeguarded. ChNPP requested the assistance of the United States Department of Energy/National Nuclear Security Administration (NNSA) with developing a new non-destructive assay (NDA) system that is capable of assaying radioactive debris stored in 55-gallon drums. The design of the system has to be tailored to the unique circumstances and work processes at the NSC construction site and the ChNPP. This paper describes the Chernobyl Drum Assay System (CDAS), the solution devised by Los Alamos National Laboratory, Sonalysts Inc., and the ChNPP, under NNSA's International Safeguards and Engagement Program (INSEP). The neutron counter measures the spontaneous fission neutrons from the {sup 238}U, {sup 240}Pu, {sup 244}Cm in a waste drum and estimates the mass contents of the SNMs in the drum by using of isotopic compositions determined by fuel burnup. The preliminary evaluation on overall measurement uncertainty shows that the system meets design performance requirements imposed by the facility.

Lee, Sang-yoon [Los Alamos National Laboratory; Browne, Michael C [Los Alamos National Laboratory; Rael, Carlos D [Los Alamos National Laboratory; Carroll, Colin J [SONALYST INC.; Sunshine, Alexander [NA-243; Novikov, Alexander [CHNPP; Lebedev, Evgeny [CHNPP

2010-01-01

235

37 CFR 1.625 - Conclusion of supplemental examination; publication of supplemental examination certificate...  

Code of Federal Regulations, 2013 CFR

...Conclusion of supplemental examination; publication of supplemental examination certificate...Conclusion of supplemental examination; publication of supplemental examination certificate...is not limited to patents and printed publications or to subject matter that has been...

2013-07-01

236

[How to improve efficacy of onychomycosis treatment?].  

PubMed

Onychomycosis is a public health concern because of its high world wide prevalence, and its potential for spread of fungal elements to others. About one half of all patients presenting to dermatologists' offices for nail disorders have onychomycosis. This kind of infection may impact upon physical, functional, and emotional aspects of life. Onychomycosis can be treated with the new generation of oral antifungals. Efficacy rates for fingernail onychomycosis are high; however, for toenail onychomycosis, efficacy rates may range from 60% to 80%. Relapse rates have been estimated to be 15% to 20% measured at 2 years following therapy initiation. Because many factors may be associated with a suboptimal clinical response, consideration to measures that reflect the most appropriate pharmacologic and supportive regimens must be made in order to meet the challenge of onychomycosis cure. In some situations supplemental therapy consisting of extra antifungal or adjunctive (topical/surgical) therapy may be beneficial. PMID:16886434

Nowicki, R

2001-01-01

237

National Institutes of Health, Office of Dietary Supplements  

MedlinePLUS

... NIH Office of Dietary Supplements Office of Dietary Supplements Strengthening Knowledge and Understanding of Dietary Supplements Searching for Scientific Literature on Dietary Supplements? Search ...

238

Dietary Supplements in Weight Reduction  

Microsoft Academic Search

We summarize evidence on the role of dietary supplements in weight reduction, with particular attention to their safety and benefits. Dietary supplements are used for two purposes in weight reduction: (a) providing nutrients that may be inadequate in calorie-restricted diets and (b) for their potential benefits in stimulating weight loss. The goal in planning weight-reduction diets is that total intake

Johanna T. Dwyer; David B. Allison; Paul M. Coates

2005-01-01

239

Nutritional Supplements for Endurance Athletes  

NASA Astrophysics Data System (ADS)

Athletes engaged in heavy endurance training often seek additional nutritional strategies to help maximize performance. Specific nutritional supplements exist to combat certain factors that limit performance beginning with a sound everyday diet. Research has further demonstrated that safe, effective, legal supplements are in fact available for today's endurance athletes. Several of these supplements are marketed not only to aid performance but also to combat the immunosuppressive effects of intense endurance training. It is imperative for each athlete to research the legality of certain supplements for their specific sport or event. Once the legality has been established, it is often up to each individual athlete to decipher the ethics involved with ingesting nutritional supplements with the sole intent of improving performance.

Rasmussen, Christopher J.

240

Dietary Supplements and Cancer Risk  

Microsoft Academic Search

\\u000a \\u000a \\u000a Key Points\\u000a \\u000a \\u000a \\u000a • \\u000a \\u000a \\u000a Approximately one-half of all Americans use dietary supplements. Thousands of supplements of multiple combinations of vitamins,\\u000a minerals, and herbs are available for purchase, but the most commonly used supplements are multivitamins and single supplements\\u000a of vitamins C and E, and calcium.\\u000a \\u000a \\u000a \\u000a \\u000a • \\u000a \\u000a \\u000a Dietary supplements can provide a large proportion of total micronutrient intake for many consumers.\\u000a \\u000a \\u000a \\u000a • 

Marian L. Neuhouser; Ruth E. Patterson; Alan R. Kristal; Emily White

241

Dietary Supplements: What You Need to Know  

MedlinePLUS

... for Consumers Selected Health Topics Women Kids & Teens - Dietary Supplements: What You Need to Know Available in PDF ( ... and your family about dietary supplements. Some Common Dietary Supplements: Acidophilus Echinacea Fiber Ginger Glucosamine and/or Chonodroitin ...

242

Effect of zinc supplementation on malaria and other causes of morbidity in west African children: randomised double blind placebo controlled trial  

Microsoft Academic Search

Objective To study the effects of zinc supplementation on malaria and other causes of morbidity in young children living in an area holoendemic for malaria in west Africa. Design Randomised, double blind, placebo controlled efficacy trial. Setting 18 villages in rural northwestern Burkina Faso. Participants 709 children were enrolled; 685 completed the trial. Intervention Supplementation with zinc (12.5 mg zinc

Olaf Mller; Heiko Becher; Anneke Baltussen van Zweeden; Diadier A Diallo; Amadou T Konate; Adjima Gbangou; Bocar Kouyate; Michel Garenne; Ruprecht Karls

2001-01-01

243

Dietary Supplements: What You Need to Know  

Center for Food Safety and Applied Nutrition (CFSAN)

... about dietary supplements? Some can be beneficial to your health - but taking supplements can also involve health risks. ... More results from www.fda.gov/food/dietarysupplements/usingdietarysupplements

244

Determining plutonium mass in spent fuel with non-destructive assay techniques - NGSU research overview and update on 6 NDA techniques  

SciTech Connect

This poster is one of two complementary posters. The Next Generation Safeguards Initiative (NGSI) of the U.S. DOE has initiated a multi-lab/university collaboration to quantify the plutonium (Pu) mass in, and detect the diversion of pins from, spent nuclear fuel assemblies with non-destructive assay (NDA). This research effort has the goal of quantifying the capability of 14 NDA techniques as well as training a future generation of safeguards practitioners. By November of 2010, we will be 1.5 years into the first phase (2.5 years) of work. This first phase involves primarily Monte Carlo modelling while the second phase (also 2.5 years) will focus on experimental work. The goal of phase one is to quantify the detection capability of the various techniques for the benefit of safeguard technology developers, regulators, and policy makers as well as to determine what integrated techniques merit experimental work, We are considering a wide range of possible technologies since our research horizon is longer term than the focus of most regulator bodies. The capability of all of the NDA techniques will be determined for a library of 64 17 x 17 PWR assemblies [burnups (15, 30, 45, 60 GWd/tU), initial enrichments (2, 3, 4, 5%) and cooling times (1, 5, 20, 80 years)]. The burnup and cooling time were simulated with each fuel pin being comprised of four radial regions. In this paper an overview of the purpose will be given as well as a technical update on the following 6 neutron techniques: {sup 252}Cf Interrogation with Prompt Neutron Detection, Delayed Neutrons, Differential Die-Away, Differential Die-Away Self-Interrogation, Passive Neutron Albedo Reactivity, Self-Integration Neutron Resonance Densitometry. The technical update will quantify the anticipated performance of each technique for the 64 assemblies of the spent fuel library.

Tobin, Stephen J [Los Alamos National Laboratory; Conlin, Jeremy L [Los Alamos National Laboratory; Evans, Louise G [Los Alamos National Laboratory; Hu, Kianwei [Los Alamos National Laboratory; Blanc, P C [Los Alamos National Laboratory; Lafleur, Am [Los Alamos National Laboratory; Menlove, H O [Los Alamos National Laboratory; Schear, M A [Los Alamos National Laboratory; Swinhoe, M T [Los Alamos National Laboratory; Croft, S [Los Alamos National Laboratory; Fensin, M L [Los Alamos National Laboratory; Freeman, C R [Los Alamos National Laboratory; Koehler, W E [Los Alamos National Laboratory; Mozin, V [Los Alamos National Laboratory; Sandoval, N P [Los Alamos National Laboratory; Lee, T H [KAERI; Cambell, L W [PNNL; Cheatham, J R [ORNL; Gesh, C J [PNNL; Hunt, A [IDAHO STATE UNIV; Ludewigt, B A [LBNL; Smith, L E [PNNL; Sterbentz, J [INL

2010-09-15

245

International energy: Subject thesaurus supplement  

SciTech Connect

This is a supplement to International Energy: Subject Thesaurus (ETDE/PUB--2(Rev.1)), which replaced DOE/TIC-7000--the EDB Subject Thesaurus. This supplement is provided periodically to keep International Energy: Subject Thesaurus recipients up-to-date on valid vocabulary terms (descriptors) used in building and maintaining several international energy information databases. Each issue contains all new terms added since the publication of the Thesaurus. Each supplement is a cumulative listing of the new terms, so that each issue replaces the previous one.

NONE

1995-05-01

246

Effect of soy isoflavone supplementation on nitric oxide metabolism and blood pressure in menopausal women  

Technology Transfer Automated Retrieval System (TEKTRAN)

Isoflavones, having chemical structures similar to estrogens, are believed to stimulate nitric oxide production and thus lower blood pressure. The efficacy of soy isoflavone supplementation to stimulate nitric oxide production and lower blood pressure in menopausal women with high normal blood press...

247

Does Multivitamin Supplementation Prevent Infections in Healthy Elderly Subjects? A Controlled trial  

Microsoft Academic Search

Summary: We performed a double blind ran- domized study in order to assess the efficacy of a multivitarnin supplement for the prevention of common infections in healthy elderly sub- jects. Non-institutionalized, independent sub- jects over 60 years of age, living in the Nevers area (central France) were recruited by an- nouncements and randomly assigned to a treat- ment or a

Michel CHAVANCE; Bernard HERBETH; Alain LEMOINE; Bao-Ping ZHU

248

Alkaline Mineral Supplementation Decreases Pain in Rheumatoid Arthri- tis Patients: A Pilot Study  

Microsoft Academic Search

The aim of this pilot study was to investigate the efficacy of an alkaline mineral supplement as a means of sup- pressing disease activity in rheumatoid arthritis (RA) patients, and to check whether any change occurs in the circulating beta-endorphin concentration. Thirty-seven patients with moderately active RA of at least two years duration, who were receiving stable pharmacological treatment, participated

Regina Maria Cseuz; Istvan Barna; Tamas Bender; Jürgen Vormann

2008-01-01

249

Zinc and copper supplementation in acute diarrhea in children: a double-blind randomized controlled trial  

Microsoft Academic Search

BACKGROUND: Diarrhea causes an estimated 2.5 million child deaths in developing countries each year, 35% of which are due to acute diarrhea. Zinc and copper stores in the body are known to be depleted during acute diarrhea. Our objectives were to evaluate the efficacy of zinc and copper supplementation when given with standard treatment to children with acute watery or

Archana Patel; Michael J Dibley; Manju Mamtani; Neetu Badhoniya; Hemant Kulkarni

2009-01-01

250

Herbs and dietary supplement use in patients with stage 5 chronic kidney disease.  

PubMed

Herbal products and dietary supplements are complementary and alternative medicine (CAM) therapies that have grown faster than any other CAM treatments. Little information is available about the use of these products in the stage 5 chronic kidney disease (CKD) population. Information on the use, safety, efficacy, adverse effects, and recommended dosages in the nondialysis population are summarized in this article. PMID:16538934

Burrowes, Jerrilynn D; Van Houten, Gloria

251

Glutamine Supplementation in Cancer Patients Receiving Bone Marrow Transplantation and High Dose Chemotherapy1,2  

Microsoft Academic Search

Glutamine supplementation of enteral and parenteral nutrition support has received increased attention in the research community over the past decade. Glutamine may become a conditionally essential nutrient during certain catabolic states, including after bone marrow transplantation (BMT). The administration of enteral or parenteral glutamine seems safe and also potentially efficacious in some patient groups undergoing intensive treatment for cancer. Studies

Thomas R. Ziegler

252

Clinical Trial of the Effect of Prenatal Fluoride Supplements in Preventing Dental Caries.  

National Technical Information Service (NTIS)

In 1977 the US Food and Drug Administration forbade advertisements claiming efficacy of prenatal fluoride supplements, due to lack of clinical data supporting such a claim. In the early 1980s, the NIDR funded a randomized clinical trial to address this is...

D. H. Leverett

1992-01-01

253

Plant based dietary supplement increases urinary pH  

PubMed Central

Background Research has demonstrated that the net acid load of the typical Western diet has the potential to influence many aspects of human health, including osteoporosis risk/progression; obesity; cardiovascular disease risk/progression; and overall well-being. As urinary pH provides a reliable surrogate measure for dietary acid load, this study examined whether a plant-based dietary supplement, one marketed to increase alkalinity, impacts urinary pH as advertised. Methods Using pH test strips, the urinary pH of 34 healthy men and women (33.9 +/- 1.57 y, 79.3 +/- 3.1 kg) was measured for seven days to establish a baseline urinary pH without supplementation. After this initial baseline period, urinary pH was measured for an additional 14 days while participants ingested the plant-based nutritional supplement. At the end of the investigation, pH values at baseline and during the treatment period were compared to determine the efficacy of the supplement. Results Mean urinary pH statistically increased (p = 0.03) with the plant-based dietary supplement. Mean urinary pH was 6.07 +/- 0.04 during the baseline period and increased to 6.21 +/- 0.03 during the first week of treatment and to 6.27 +/- 0.06 during the second week of treatment. Conclusion Supplementation with a plant-based dietary product for at least seven days increases urinary pH, potentially increasing the alkalinity of the body.

Berardi, John M; Logan, Alan C; Rao, A Venket

2008-01-01

254

Antioxidative and immunomodulatory effects of tributyrin supplementation on experimental colitis.  

PubMed

Tributyrin (TBT) is a TAG composed of three butyric acids that has beneficial effects on ulcerative colitis due to its trophic, anti-inflammatory, pro-apoptotic and anti-carcinogenic properties. The goal of the present study was to evaluate the efficacy and mechanisms of action of TBT supplementation in the prevention of mucosal damage in experimental colitis. Mice received either a control diet or a TBT-supplemented diet for 15 d. Colitis was induced by dextran sodium sulphate administration during the last 7 d. Mucosal damage and the activation of immune cells and cytokines were determined by histological score, flow cytometry and ELISA. Leucocyte rolling and adhesion were assessed by intravital microscopy. Oxidative stress was determined by monitoring hydroperoxide concentration and evaluating superoxide dismutase (SOD) and catalase activities. Intestinal permeability was analysed using diethylenetriaminepentaacetate acid (99mTcDTPA). Compared with the colitis group, the animals in the colitis+TBT group had reduced mucosal damage and neutrophil and eosinophil mucosal infiltration, which were associated with a higher percentage of regulatory T cells (Treg) and higher levels of transforming growth factor ? and IL-10 in the lamina propria. The level of in vivo leucocyte adhesion in the colon microvasculature was reduced after TBT supplementation. A lower level of hydroperoxide and higher levels of SOD and catalase activities were associated with TBT supplementation. TBT-supplemented mice showed reduced intestinal permeability to the levels intermediate between the control and colitis groups. In conclusion, the present results show that TBT has positive effects on colonic restructuring in experimental colitis. Additionally, TBT supplementation changes the immune response by controlling inflammation and regulating the expression of anti-inflammatory cytokines and Treg. PMID:22906779

Leonel, Alda J; Teixeira, Lílian G; Oliveira, Rafael P; Santiago, Andrezza F; Batista, Nathália V; Ferreira, Talita R; Santos, Rosana C; Cardoso, Valbert N; Cara, Denise C; Faria, Ana M C; Alvarez-Leite, Jacqueline

2012-08-20

255

Motivators and barriers to prenatal supplement use among minority women in the United States.  

PubMed

Minority women in the United States are at a higher risk of iron deficiency and less likely to report use of prenatal supplements compared with non-Hispanic white women. Little information exists on the perceived benefits and barriers to prenatal supplement use. We analyzed the results of 12 focus groups conducted with African-American and Hispanic women (n=104). Groups were equally divided into consistent (five to seven times per week for 3 or more months) and inconsistent (zero to four times per week for 0 to 2 months) users and by race/ethnicity. We examined motivators and barriers to prenatal supplement use and identified common themes; we also compared responses between consistent and inconsistent users, and between African American and Hispanic women. For all groups, positive effects, convenient supply, affordability, and reinforcement by health care providers enhanced adherence. Common barriers were prenatal supplement qualities, adverse effects, and poor communication from health care providers about the benefits of use. Common motivators among consistent users included social network reinforcement of daily intake and fear of adverse effects to the fetus if prenatal supplements were not taken. Common barriers among inconsistent users included skepticism toward the efficacy and necessity of prenatal supplements and the health care provider assenting to nonadherence. Prenatal supplement use was influenced by multiple factors in women's daily lives. Adherence will likely be enhanced by reducing barriers related to prenatal supplement qualities and adverse effects, improving social network support, and improving health care provider interactions. PMID:19103329

Tessema, Judith; Jefferds, Maria Elena; Cogswell, Mary; Carlton, Ewa

2009-01-01

256

Dietary supplements for improving body composition and reducing body weight: where is the evidence?  

PubMed

Weight-loss supplements typically fall into 1 of 4 categories depending on their hypothesized mechanism of action: products that block the absorption of fat or carbohydrate, stimulants that increase thermogenesis, products that change metabolism and improve body composition, and products that suppress appetite or give a sense of fullness. Each category is reviewed, and an overview of the current science related to their effectiveness is presented. While some weight-loss supplements produce modest effects (<2 kg weight loss), many have either no or few randomized clinical trials examining their effectiveness. A number of factors confound research results associated with the efficacy of weight-loss supplements, such as small sample sizes, short intervention periods, little or no follow-up, and whether the supplement is given in combination with an energy-restricted diet or increased exercise expenditure. There is no strong research evidence indicating that a specific supplement will produce significant weight loss (>2 kg), especially in the long term. Some foods or supplements such as green tea, fiber, and calcium supplements or dairy products may complement a healthy lifestyle to produce small weight losses or prevent weight gain over time. Weight-loss supplements containing metabolic stimulants (e.g., caffeine, ephedra, synephrine) are most likely to produce adverse side effects and should be avoided. PMID:22465867

Manore, Melinda M

2012-04-01

257

Gas transport properties of poly(1,5-naphthalene-2,2?-bis(3,4-phthalic) hexafluoropropane) diimide (6FDA1,5-NDA) dense membranes  

Microsoft Academic Search

The intrinsic gas transport properties of permeation, diffusion and sorption for He, O2, N2, CH4 and CO2 in aromatic polyimide, poly(1,5-naphthalene-2,2?-bis(3,4-phthalic) hexafluoropropane) diimide (6FDA-1,5-NDA) dense membranes were investigated. The permeation of pure gases of He, O2, N2, CH4 and CO2 was measured with a temperature-controlled permeation cell while the sorption isotherm was obtained from the Cahn 2000 microbalance sorption cell.The

R. Wang; S. S. Chan; Y. Liu; T. S. Chung

2002-01-01

258

Sera Koflullar›nda Yetifltirilen ‹ki Krizantem Çeflidinin (Yellow Delta ve Cerise Delta) Baz› Makro Besinleri Absorpsiyonlar›n›n ‹ncelenmesi  

Microsoft Academic Search

Özet: Bu araflt›rma, Antalya'da yetifltiricilii geniflleme eyiliminde olan krizantem bitkisinin topraktan kald›rd›¤› makro besin maddeleri miktarlar›n›n deiflimini incelemek amac›yla yürütülmüfltür. Bu amaçla yetifltirici koflullar›nda plastik serada iki krizantem çeflidi (Yellow Delta ve Cerise Delta) yetifltirilmifl ve ikifler haftal›k dönemler fleklinde, fide hariç 8 defa bitki örneklemesi yap›lm›flt›r. Dekardan Yellow Delta krizantem çeflidi taraf›ndan kald›r›lan makro besin maddeleri miktarlar› 14.86 kg

Mustafa KAPLAN

259

Metabolik sendrom tan› kriterleri hakk›nda yaflanan küresel kargafla: K›lavuzlar›n anlaflamad›¤› nokta nedir? Global confusion on the diagnostic criteria for metabolic syndrome: What is the point that guidelines can not agree?  

Microsoft Academic Search

ÖZET Pek çok ulusal ve uluslar aras› dernek kendi metabolik sendrom tan› kriterlerini tan›mlam›flt›r. Bu tan› k›lavuzlar›n›n çeflitlilii, baz› yazarlar› metabolik sendrom tan›m›ndan vazgeçilmesini savunmaya teflvik etmifltir. Bu makalede k›lavuzlar›n tan› kriterleri aras›ndaki farkl›l›klar›n ir- delenmesi amaçlanm›fl, karfl›laflt›rmal› olarak gözden geçirilmifltir. Görülmüfltür ki, k›lavuzlar›n çeflitliliine ramen, aralar›nda kavramsal bir uyum söz konusudur. Fakat hangi deiflkenlerle, hangi eflik deerler afl›ld›¤›nda tan›

Selçuk Dadelen; Tomris Erbafl

260

Regulatory focus, self-efficacy and outcome expectations as drivers of motivation to consume healthy food products.  

PubMed

In this paper we apply the principle of Regulatory Focus Theory to investigate the interaction between self-efficacy and outcome expectations on individuals' intentions to adopt health behaviors. The participants, 959 individuals (Survey 1) and 2400 individuals (Survey 2), reported self-efficacy beliefs and outcome expectations with regard to the consumption of omega-3 supplements and omega-3-enriched food products. We found that the relationship prevention outcome expectations-intention was significantly attenuated at low levels of self-efficacy and strengthened at high levels of self-efficacy, respectively; whereas, the relationship promotion outcome expectations-intention was unaffected by the perceived levels of self-efficacy. The implications suggest that consumers' motivation to adopt healthy food products, such as omega-3 supplements and omega-3 enriched products, should be encouraged by stimulating promotion outcome expectations. However, when a prevention frame is used, the individuals' motivation should be significantly enhanced by self-efficacy beliefs. PMID:22595287

Tudoran, Ana Alina; Scholderer, Joachim; Brunsø, Karen

2012-05-14

261

Effect of low-dose, short-duration creatine supplementation on anaerobic exercise performance.  

PubMed

To examine the efficacy of a low-dose, short-duration creatine monohydrate supplement, 40 physically active men were randomly assigned to either a placebo or creatine supplementation group (6 g of creatine monohydrate per day). Testing occurred before and at the end of 6 days of supplementation. During each testing session, subjects performed three 15-second Wingate anaerobic power tests. No significant (p > 0.05) group or time differences were observed in body mass, peak power, mean power, or total work. In addition, no significant (p > 0.05) differences were observed in peak power, mean power, or total work. However, the change in the rate of fatigue of total work was significantly (p < 0.05) lower in the creatine supplementation group than in the placebo group, indicating a reduced fatigue rate in subjects supplementing with creatine compared with the placebo. Although the results of this study demonstrated reduced fatigue rates in patients during high-intensity sprint intervals, further research is necessary in examining the efficacy of low-dose, short-term creatine supplementation. PMID:15903359

Hoffman, Jay R; Stout, Jeffrey R; Falvo, Michael J; Kang, Jie; Ratamess, Nicholas A

2005-05-01

262

What's Medicare Supplement (Medigap) Insurance?  

MedlinePLUS

... Check your enrollment Find doctors, hospitals, & facilities Your Medicare Costs Get help paying costs Part A costs Part ... Baltimore, MD 21244 Sign Up / Change Plans Your Medicare Costs What Medicare Covers Drug Coverage (Part D) Supplements & ...

263

Tips for Dietary Supplement Users  

Center for Food Safety and Applied Nutrition (CFSAN)

... on the functions and potential benefits of vitamins and minerals, as well as ... While vitamin and mineral supplements are widely used and generally ... More results from www.fda.gov/food/dietarysupplements/usingdietarysupplements

264

?-Supplemented Subgroups and Their Properties  

Microsoft Academic Search

A subgroup H is called ?-supplemented in a finite group G, if there exists a subgroup B of G such that G = HB and H1B is a proper subgroup of G for any maximal subgroup H1 of H. In this article, we investigate the influence of ?-supplementation of some primary subgroups in finite groups. Some new results about supersolvable groups and

Long Miao; Yanming Wang

2009-01-01

265

Cardiovascular effects of calcium supplementation  

Microsoft Academic Search

Trials in normal older women and in patients with renal impairment suggest that calcium supplements increase the risk of cardiovascular\\u000a disease. To further assess their safety, we recently conducted a meta-analysis of trials of calcium supplements, and found\\u000a a 27–31% increase in risk of myocardial infarction and a 12–20% increase in risk of stroke. These findings are robust because\\u000a they

I. R. Reid; M. J. Bolland; A. Avenell; A. Grey

2011-01-01

266

Simultaneous Weekly Supplementation of Iron and Zinc Is Associated with Lower Morbidity Due to Diarrhea and Acute Lower Respiratory Infection in Bangladeshi Infants1  

Microsoft Academic Search

Given the high prevalence of micronutrient deficiencies and infectious diseases in infants in devel- oping countries, an evaluation of the efficacy of different micronutrient formulations on infant morbidity is a priority. The efficacy of weekly supplementation of four different micronutrient formulations on diarrhea and acute lower respiratory infection (ALRI) morbidity was evaluated in Bangladeshi infants. In a double-blind, randomized, controlled

Abdullah H. Baqui; K. Zaman; Lars Ake Persson; Shams El Arifeen; Mohammad Yunus; Nazma Begum; Robert E. Black

267

Enhanced Reduction of Fasting Total Homocysteine Levels With Supraphysiological Versus Standard Multivitamin Dose Folic Acid Supplementation in Renal Transplant Recipients  

Microsoft Academic Search

The mild fasting hyperhomocysteinemia commonly observed in chronic (ie, $6 months posttransplantation) renal transplant recipients (RTRs) can be effectively treated with combined B-vitamin supplementation featuring supraphysiological doses of folic acid. There are no controlled data evaluating the comparative efficacy of supraphysiological versus standard multivitamin dose folic acid supplementation in reducing fasting total homocysteine (tHcy) levels among RTRs. We block-randomized 60

Andrew J. Beaulieu; Reginald Y. Gohh; Haewook Han; David Hakas; Paul F. Jacques; Jacob Selhub; Andrew G. Bostom

268

An herbal supplement containing Ma Huang-Guarana for weight loss: a randomized, double-blind trial  

Microsoft Academic Search

OBJECTIVE: To examine in overweight humans the short-term safety and efficacy for weight loss of an herbal supplement containing Ma Huang, Guarana and other ingredients.DESIGN: An 8 week randomized, double-blind placebo controlled study of a herbal dietary supplement (72 mg\\/day ephedrine alkaloids and 240 mg\\/day caffeine).SUBJECTS: Overweight men and women (body mass index, ?29 and ?35 kg\\/m2).MEASUREMENTS: The primary outcome

CN Boozer; JA Nasser; SB Heymsfield; V Wang; G Chen; JL Solomon

2001-01-01

269

Timings for Efficacy Studies  

Center for Biologics Evaluation and Research (CBER)

... HPV-009, A double blind, controlled, randomized, phase III study of the efficacy of an HPV16/18 VLP vaccine in the prevention of advanced cervical ... More results from www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts

270

Supplement use during an intergroup clinical trial for breast cancer (S0221).  

PubMed

The use of supplements during chemotherapy is controversial, partly due to the potential effect of antioxidants on reduced efficacy of chemotherapy-related cytotoxicity. We examined supplement use among breast cancer patients registered to a clinical trial (SWOG 0221) before diagnosis and during treatment. Patients (n = 1,467) completed questionnaires regarding multivitamin and supplement use at trial registration (baseline) to capture use before diagnosis. Of these patients, 1,249 completed a 6-month followup questionnaire to capture use during treatment. We examined the use of vitamins C, D, E, B6, B12, folic acid, and calcium at these timepoints, as well as physician recommendations regarding supplement use. The use of vitamins C, E, folic acid, and calcium decreased during treatment, while the use of vitamin B6 increased. Five hundred seventy four patients (51 %) received no physician recommendations regarding supplement use. Among the remaining 49, 10 % were advised not to take multivitamins and/or supplements, 7 % were advised to use only multivitamins, and 32 % received recommendations to use multivitamins and/or supplements. Among patients who took vitamin C before diagnosis, those who were advised not to take supplements were >5 times more likely not to use of vitamin C during treatment than those not advised to stop use (OR = 5.27, 95 % CI 1.13-24.6). Previous non-users who were advised to take a multivitamin were nearly 5 times more likely to use multivitamins during treatment compared to those who received no recommendation (OR = 4.66, 95 % CI 2.10-10.3). In this clinical trial for high-risk breast cancer, supplement use generally decreased during treatment. Upon followup from the clinical trial, findings regarding supplement use and survival outcomes will better inform physician recommendations for patients on adjuvant chemotherapy. PMID:23306462

Zirpoli, Gary R; Brennan, Patrick M; Hong, Chi-Chen; McCann, Susan E; Ciupak, Gregory; Davis, Warren; Unger, Joseph M; Budd, G Thomas; Hershman, Dawn L; Moore, Halle C F; Stewart, James; Isaacs, Claudine; Hobday, Timothy; Salim, Muhammad; Hortobagyi, Gabriel N; Gralow, Julie R; Albain, Kathy S; Ambrosone, Christine B

2013-01-10

271

Psychology of Supplementation in Sport and Exercise: Motivational Antecedents and Biobehavioral Outcomes  

NASA Astrophysics Data System (ADS)

Research concerning the physiological and biobehavioral effects of supplements commonly used in sport or exercise settings has multiplied rapidly over the last decade. However, less attention has been directed to understanding the motivational pathways leading to sport and exercise supplement use. This chapter summarizes known usage rates for sport/fitness supplements and describes motivational theories and constructs that may be of use for understanding individuals' use of these substances. In this respect, we contend that researchers should consider behavioral approaches, the theory of planned behavior, balance theory, achievement goal theory, social physique anxiety, and muscle dysmorphia as useful for developing an understanding of the psychological influences on supplement use. For some of the latter theories/constructs, research has already shown support for their explanatory abilities, whereas research is scant and the utility for understanding sport/exercise supplement use is yet to be determined for many of the theories. In addition to describing the motivation behind supplement use, this chapter summarizes the biobehavioral effects of a select group of supplements commonly used to improve performance, fitness, or health. Specifically, we consider psychobiological effects of caffeine, creatine, Ginkgo biloba, and St. John's wort related to enhanced arousal, improved memory and cognition, enhanced brain function and protection, and reduced depression. There is promising initial evidence for the efficacy of these compounds in producing favorable psychological outcomes, although certain shortcomings of many studies on these compounds must be taken into account before reaching definitive conclusions.

Lutz, Rafer; Arent, Shawn

272

The effects of chronic taurine supplementation on motor learning.  

PubMed

Taurine is one of the most abundant nonprotein amino acids shown to be essential for the development, survival, and growth of vertebrate neurons. We previously demonstrated that chronic taurine supplementation during neonatal development results in changes in the GABAergic system (El Idrissi, Neurosci Lett 436:19-22, 2008). The brains of mice chronically treated with taurine have decreased levels of GABA(A)? subunits and increased expression of GAD and GABA, which contributes to hyperexcitability. This down regulation of GABA(A)receptor subunit expression and function may be due to a sustained interaction of taurine with GABA(A)receptors. This desensitization decreases the efficacy of the inhibitory synapses at the postsynaptic membrane. If changes occur in the GABAergic system as a possible compensatory mechanism due to taurine administration, then it is important to study all aspects by which taurine induces hyperexcitability and affects motor behavior. We therefore hypothesized that modification of the GABAergic system in response to taurine supplementation influences motor learning capacity in mice. To test this hypothesis, the rotarod task was employed after chronic taurine supplementation in drinking water (0.05% for 4 weeks). Control animals receiving no taurine supplementation were also tested in order to determine the difference in motor learning ability between groups. Each animal was trained on the rotarod apparatus for 7 days at an intermediate speed of 24 rpm in order to establish baseline performance. On the testing day, each animal was subjected to eight different predefined speeds (5, 8, 15, 20, 24, 31, 33, and 44 rpm). From our observations, the animals that underwent chronic taurine supplementation appeared to have a diminished motor learning capacity in comparison to control animals. The taurine-fed mice displayed minor improvements after repeated training when compared to controls. During the testing session the taurine-fed mice also exhibited a shorter latency to fall, as the task requirements became more demanding. PMID:23392934

Santora, Allison; Neuwirth, Lorenz S; L'Amoreaux, William J; Idrissi, Abdeslem El

2013-01-01

273

Teaching diversity by using instructional technology : Application of self-efficacy and cultural competence  

Microsoft Academic Search

Purpose – This study examines the use of an instructional technology of utilizing the online forum as a tool for improving self-efficacy related to cultural competency among social work graduate students. As a supplement to face-to-face classes, students (n=103) were encouraged to participate in an Online Diversity Forum (ODF). Design\\/methodology\\/approach – Forum participants assessed their perceived level of self-efficacy related

E. Othelia Lee; Elizabeth Bertera

2007-01-01

274

Nutritional Supplements for Strength Power Athletes  

NASA Astrophysics Data System (ADS)

Over the last decade research involving nutritional supplementation and sport performance has increased substantially. Strength and power athletes have specific needs to optimize their performance. Nutritional supplementation cannot be viewed as a replacement for a balanced diet but as an important addition to it. However, diet and supplementation are not mutually exclusive, nor does one depend on the other. Strength and power athletes have four general areas of supplementation needs. First, strength athletes need supplements that have a direct effect on performance. The second group of supplements includes those that promote recovery. The third group comprises the supplements that enhance immune function. The last group of supplements includes those that provide energy or have a direct effect on the workout. This chapter reviews the key supplements needed to optimize the performance and training of the strength athlete.

Wilborn, Colin

275

Ephedra: yesterday, DSHEA, and tomorrow--a ten year perspective on the Dietary Supplement Health and Education Act of 1994.  

PubMed

The Dietary Supplement Heath and Education Act of 1994 (DSHEA) established the regulatory framework for dietary supplements in the United States, triggering the growth of a multi-billion dollar industry. Ephedra is a dietary supplement used for weight loss. However, due to its sympathomimetic activity, it has caused stroke, cardiac arrhythmia, and death. Accordingly, the Food and Drug Administration (FDA) has prohibited its sale in the United States since April 12, 2004. Consequently, numerous other dietary supplements are attempting to fill the marketing void. An evaluation of these products demonstrates a general lack of efficacy and safety data. Thus, in the ten years since the passage of DSHEA, the dietary supplement industry remains controversial and a concern for consumer safety. PMID:16520299

Seamon, Matthew J; Clauson, Kevin A

2005-01-01

276

The effect of the dietary supplement, Chitosan, on body weight: a randomised controlled trial in 250 overweight and obese adults  

Microsoft Academic Search

CONTEXT: Chitosan, a deacetylated chitin, is a widely available dietary supplement purported to decrease body weight and serum lipids through gastrointestinal fat binding. Although evaluated in a number of trials, its efficacy remains in dispute.OBJECTIVE: To evaluate the efficacy of chitosan for weight loss in overweight and obese adults.DESIGN AND SETTING: A 24-week randomised, double-blind, placebo-controlled trial, conducted at the

C Ni Mhurchu; S D Poppitt; A-T McGill; F E Leahy; D A Bennett; R B Lin; D Ormrod; L Ward; C Strik; A Rodgers

2004-01-01

277

Alpha-lipoic acid supplementation and diabetes  

PubMed Central

Diabetes is a common metabolic disorder that is usually accompanied by increased production of reactive oxygen species or by impaired antioxidant defenses. Importantly, oxidative stress is particularly relevant to the risk of cardiovascular disease. Alpha-lipoic acid (LA), a naturally occurring dithiol compound, has long been known as an essential cofactor for mitochondrial bioenergetic enzymes. LA is a very important micronutrient with diverse pharmacologic and antioxidant properties. Pharmacologically, LA improves glycemic control and polyneuropathies associated with diabetes mellitus; it also effectively mitigates toxicities associated with heavy metal poisoning. As an antioxidant, LA directly terminates free radicals, chelates transition metal ions, increases cytosolic glutathione and vitamin C levels, and prevents toxicities associated with their loss. These diverse actions suggest that LA acts by multiple mechanisms both physiologically and pharmacologically. Its biosynthesis decreases as people age and is reduced in people with compromised health, thus suggesting a possible therapeutic role for LA in such cases. Reviewed here is the known efficacy of LA with particular reference to types 1 and 2 diabetes. Particular attention is paid to the potential benefits of LA with respect to glycemic control, improved insulin sensitivity, oxidative stress, and neuropathy in diabetic patients. It appears that the major benefit of LA supplementation is in patients with diabetic neuropathy.

Singh, Uma; Jialal, Ishwarlal

2009-01-01

278

Fitness supplements as a gateway substance for anabolic-androgenic steroid use.  

PubMed

Approximately 3.0% of young Americans have used anabolic-androgenic steroids (AAS). A traditional model of adolescent substance use, the gateway hypothesis, suggests that drug use follows a chronological, causal sequence, whereby initial use of a specific drug leads to an increased likelihood of future drug use. Therefore, the use of illicit appearance and performance enhancing drugs (APED), such as AASs, also follows an analogous progression, whereby legal APEDs, (e.g., nutritional supplements) precedes illicit APED use. We examined the relationship between nutritional supplement use, beliefs about APEDs, and APED use in 201 male (n = 100) and female (n = 101) undergraduates. Participants completed measures of muscle dysmorphia (MDDI), body checking (BCQ, MBCQ), eating disorder symptoms (EDE-Q), perfectionism (FMPS), positive beliefs about the efficacy-safety of AAS use and APED use patterns. A series of covariance structure models (CSM) showed body image disturbance, compulsive exercise, illicit drug use, and perfectionism, independent of gender, were significant predictors of positive beliefs about AAS. Those who used both fat burning and muscle building supplements reported the strongest beliefs in AAS efficacy-safety, which was associated with higher likelihood of current illicit APED use. There was evidence of significant indirect relationships between supplement use and illicit APED use through contact with other AAS users and beliefs about AAS. The potential role for nutritional supplement use in the initiation of illegal APED use is discussed. Future prevention efforts may benefit from targeting legal APED users in youth. PMID:22486333

Hildebrandt, Tom; Harty, Seth; Langenbucher, James W

2012-04-09

279

21 CFR 119.1 - Dietary supplements containing ephedrine alkaloids.  

Code of Federal Regulations, 2013 CFR

...false Dietary supplements containing ephedrine alkaloids. 119.1 Section 119...119.1 Dietary supplements containing ephedrine alkaloids. Dietary supplements containing ephedrine alkaloids present an...

2013-04-01

280

21 CFR 119.1 - Dietary supplements containing ephedrine alkaloids.  

Code of Federal Regulations, 2010 CFR

...false Dietary supplements containing ephedrine alkaloids. 119.1 Section 119...119.1 Dietary supplements containing ephedrine alkaloids. Dietary supplements containing ephedrine alkaloids present an...

2009-04-01

281

21 CFR 119.1 - Dietary supplements containing ephedrine alkaloids.  

Code of Federal Regulations, 2010 CFR

...false Dietary supplements containing ephedrine alkaloids. 119.1 Section 119...119.1 Dietary supplements containing ephedrine alkaloids. Dietary supplements containing ephedrine alkaloids present an...

2010-04-01

282

NDA Review Memo (+Addendum)  

Center for Biologics Evaluation and Research (CBER)

Text Version... criteria for the European trials included a history of heart, kidney, liver ... HS-J3-30-lJS), exclusion criteria included previous cardiac surgery, anemia ... More results from www.fda.gov/downloads/biologicsbloodvaccines/bloodbloodproducts

283

NDA 021071 Rosiglitazone  

Center for Drug Evaluation (CDER)

Text Version... dropout due to edema in this trial, mirroring a criticism leveled at the ... or rosiglitazone were conducted prior to 2010 and published in the literature. ... More results from www.fda.gov/downloads/drugs/drugsafety

284

Telaprevir NDA 201917  

Center for Biologics Evaluation and Research (CBER)

Text Version... Phase 3 – Rash Special Search Criteria (SSC) – Events of Special Interest (ESI) ... ESA use generally prohibited • Anemia SSC Page 41. 41 ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

285

Clinical Review for NDA ##-###  

Center for Drug Evaluation (CDER)

Text Version... This is not the case with OCD. ... OCD did not respond to TCAs in general with the one exception being clomipramine. Page 5. CLINICAL REVIEW ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

286

NDA 202714 Carfilzomib (Kyprolis™)  

Center for Biologics Evaluation and Research (CBER)

Text Version... N = 266 n (%) Bortezomib 231 (86.8) Lenalidomide* 231 (86.8) Thalidomide* 148 (56.0) Anthracycline (any) 98 (36.8) ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

287

Tretinoin (NDA 020475)  

Center for Biologics Evaluation and Research (CBER)

Text Version... with the diagnosis or assessment of acne vulgaris (eg, on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform ... More results from www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation

288

New Drug Application (NDA)  

Center for Drug Evaluation (CDER)

... whole story, including what happened during the clinical tests, what the ... and also to the design, production, manufacturing, and testing of regulated ... More results from www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved

289

Supplemental Instruction in Developmental Mathematics  

ERIC Educational Resources Information Center

Mirroring the changing demographics of the nation, the community college student population continues to grow in size and diversity. Almost half of all students who enter these institutions need at least one remedial course--which is often developmental mathematics. Developed in 1973, Supplemental Instruction (SI) has quickly gained recognition as…

Phelps, Julie M.; Evans, Ruby

2006-01-01

290

Laboratory Animal Welfare Supplement IV.  

ERIC Educational Resources Information Center

|This document is the fourth supplement to a 1984 bibliography on laboratory animal welfare. Items presented were selected because they represent some of the most significant of those providing recent information or because they were considered useful. The period covered is October, 1986 through October, 1987. Monographs, conference proceedings,…

Gluckstein, Fritz P., Comp.

291

Putting science behind botanical supplements  

Technology Transfer Automated Retrieval System (TEKTRAN)

This report describes the goals and activities of the Center for Research on Botanical Dietary Supplements at Iowa State University and the University of Iowa, a multidisciplinary effort to investigate the bioactivity and bioavailability of three genera of medicinal plants: Echinacea, Hypericum, and...

292

Carbohydrate Supplementation and Resistance Training  

Microsoft Academic Search

There is a growing body of evidence suggesting that the performance of resistance-training exercises can elicit a sig- nificant glycogenolytic effect that potentially could result in performance decrements. These decrements may result in less than optimal physiological adaptations to training. Cur- rently some scientific evidence suggests that carbohydrate supplementation prior to and during high-volume resistance training results in the maintenance

G. GREGORY HAFF; MARK J. LEHMKUHL; LORA B. McCOY; MICHAEL H. STONE

2003-01-01

293

Supplementation of Alpha 1-Antitrypsin.  

National Technical Information Service (NTIS)

The aim of the study is to explore the feasibility of preparing alpha 1-antitrypsin from the plasma of carefully screened donors who have been found to be free of testable liver abnormalities and eventually supplement patients having inherited alpha 1-ant...

B. H. Bowman G. Powell D. R. Barnett J. C. Gan

1975-01-01

294

Efficacy of climate forcings  

NASA Astrophysics Data System (ADS)

We use a global climate model to compare the effectiveness of many climate forcing agents for producing climate change. We find a substantial range in the "efficacy" of different forcings, where the efficacy is the global temperature response per unit forcing relative to the response to CO2 forcing. Anthropogenic CH4 has efficacy ˜110%, which increases to ˜145% when its indirect effects on stratospheric H2O and tropospheric O3 are included, yielding an effective climate forcing of ˜0.8 W/m2 for the period 1750-2000 and making CH4 the largest anthropogenic climate forcing other than CO2. Black carbon (BC) aerosols from biomass burning have a calculated efficacy ˜58%, while fossil fuel BC has an efficacy ˜78%. Accounting for forcing efficacies and for indirect effects via snow albedo and cloud changes, we find that fossil fuel soot, defined as BC + OC (organic carbon), has a net positive forcing while biomass burning BC + OC has a negative forcing. We show that replacement of the traditional instantaneous and adjusted forcings, Fi and Fa, with an easily computed alternative, Fs, yields a better predictor of climate change, i.e., its efficacies are closer to unity. Fs is inferred from flux and temperature changes in a fixed-ocean model run. There is remarkable congruence in the spatial distribution of climate change, normalized to the same forcing Fs, for most climate forcing agents, suggesting that the global forcing has more relevance to regional climate change than may have been anticipated. Increasing greenhouse gases intensify the Hadley circulation in our model, increasing rainfall in the Intertropical Convergence Zone (ITCZ), Eastern United States, and East Asia, while intensifying dry conditions in the subtropics including the Southwest United States, the Mediterranean region, the Middle East, and an expanding Sahel. These features survive in model simulations that use all estimated forcings for the period 1880-2000. Responses to localized forcings, such as land use change and heavy regional concentrations of BC aerosols, include more specific regional characteristics. We suggest that anthropogenic tropospheric O3 and the BC snow albedo effect contribute substantially to rapid warming and sea ice loss in the Arctic. As a complement to a priori forcings, such as Fi, Fa, and Fs, we tabulate the a posteriori effective forcing, Fe, which is the product of the forcing and its efficacy. Fe requires calculation of the climate response and introduces greater model dependence, but once it is calculated for a given amount of a forcing agent it provides a good prediction of the response to other forcing amounts.

Hansen, J.; Sato, M.; Ruedy, R.; Nazarenko, L.; Lacis, A.; Schmidt, G. A.; Russell, G.; Aleinov, I.; Bauer, M.; Bauer, S.; Bell, N.; Cairns, B.; Canuto, V.; Chandler, M.; Cheng, Y.; Del Genio, A.; Faluvegi, G.; Fleming, E.; Friend, A.; Hall, T.; Jackman, C.; Kelley, M.; Kiang, N.; Koch, D.; Lean, J.; Lerner, J.; Lo, K.; Menon, S.; Miller, R.; Minnis, P.; Novakov, T.; Oinas, V.; Perlwitz, Ja.; Perlwitz, Ju.; Rind, D.; Romanou, A.; Shindell, D.; Stone, P.; Sun, S.; Tausnev, N.; Thresher, D.; Wielicki, B.; Wong, T.; Yao, M.; Zhang, S.

2005-09-01

295

Protein supplementation in u.s. Military personnel.  

PubMed

Protein supplements (PSs) are, after multivitamins, the most frequently consumed dietary supplement by U.S. military personnel. Warfighters believe that PSs will improve health, promote muscle strength, and enhance physical performance. The estimated prevalence of regular PS use by military personnel is nearly 20% or more in active-duty personnel, which is comparable to collegiate athletes and recreationally active adults, but higher than that for average U.S. civilians. Although the acute metabolic effects of PS ingestion are well described, little is known regarding the benefits of PS use by warfighters in response to the metabolic demands of military operations. When dietary protein intake approaches 1.5 g · kg(-1) · d(-1), and energy intake matches energy expenditure, the use of PSs by most physically active military personnel may not be necessary. However, dismounted infantry often perform operations consisting of long periods of strenuous physical activity coupled with inadequate dietary energy and protein intake. In these situations, the use of PSs may have efficacy for preserving fat-free mass. This article reviews the available literature regarding the prevalence of PS use among military personnel. Furthermore, it highlights the unique metabolic stressors affecting U.S. military personnel and discusses potential conditions during which protein supplementation might be beneficial. PMID:24027181

Pasiakos, Stefan M; Montain, Scott J; Young, Andrew J

2013-09-11

296

Steroids/Nutritional Supplements/Antibiotics  

MedlinePLUS

Steroids/Nutritional Supplements/Antibiotics There are multiple steroid/supplemental treatments for Duchenne although there is little agreement ( ... creatine and Duchenne continue. back to top Anabolic steroids These, which act to build tissues in the ...

297

2006 Biological License Application Supplement Approvals  

Center for Biologics Evaluation and Research (CBER)

... 2006 Biological License Application Supplement Approvals. ... The supplements are listed by date ... Vaccine (Diphtheria CRM197 Protein), Changes to ... More results from www.fda.gov/biologicsbloodvaccines/developmentapprovalprocess/biologicalapprovalsbyyear

298

Dietary Supplements: An Advertising Guide for Industry.  

National Technical Information Service (NTIS)

The dietary supplement industry is a dynamic one. Specific research on the associations between supplements and health is accumulating rapidly. The number of products -- and the variety of uses for which they are promoted -- have increased significantly i...

1998-01-01

299

Calcium Supplements: Do Men Need Them Too?  

MedlinePLUS

... may be reprinted for personal, noncommercial use only. Calcium supplements: Do men need them too? By Mayo ... share your e-mail address Sign up Question Calcium supplements: Do men need them too? Should men ...

300

Efficacy of a First-Grade Responsiveness-to-Intervention Prevention Model for Struggling Readers  

ERIC Educational Resources Information Center

|This randomized control trial examined the efficacy of a multitiered supplemental tutoring program within a first-grade responsiveness-to-intervention prevention model. Struggling first-grade readers (n = 649) were screened and progress monitored at the start of the school year. Those identified as unresponsive to general education Tier 1 (n =…

Gilbert, Jennifer K.; Compton, Donald L.; Fuchs, Douglas; Fuchs, Lynn S.; Bouton, Bobette; Barquero, Laura A.; Cho, Eunsoo

2013-01-01

301

Efficacy of nutritional aupplementation therapy in depleted patients with chronic obstructive pulmonary disease  

Microsoft Academic Search

ObjectiveWeight loss and muscle wasting adversely affect morbidity and mortality in patients with chronic obstructive pulmonary disease (COPD). Maintenance systemic glucocorticosteroids, prescribed in a substantial number of patients, further contribute to muscle weakness. We investigated the efficacy of oral nutritional supplementation therapy in depleted patients with COPD.

Eva C Creutzberg; Emiel F. M Wouters; Rob Mostert; Clarie A. P. M Weling-Scheepers; Annemie M. W. J Schols

2003-01-01

302

Efficacy of Computer-Assisted Instruction for the Development of Early Literacy Skills in Young Children  

ERIC Educational Resources Information Center

|Two studies examined the efficacy of using computer-assisted instruction (CAI) to supplement a phonics-based reading curriculum for preschoolers and kindergartners in an urban public school system. The CAI programs provided exercises in phonological awareness and basic phonics skills. We compared treatment classes using CAI with control classes…

Macaruso, Paul; Rodman, Alyson

2011-01-01

303

Belief in the efficacy of alternative medicine among general practitioners in the Netherlands  

Microsoft Academic Search

A survey among 293 GPs in the Netherlands showed that many believe in the efficacy of common alternative procedures. High scores were especially found for manual therapy, yoga, acupuncture, hot bath therapy and homoeopathy. Other procedures, such as iridology, faith healing and many food supplements, were considered less useful.

Paul Knipschild; Jos Kleijnen; Gerben ter Riet

1990-01-01

304

14 CFR 91.211 - Supplemental oxygen.  

Code of Federal Regulations, 2013 CFR

... 2013-01-01 false Supplemental oxygen. 91.211 Section 91.211 Aeronautics...Requirements § 91.211 Supplemental oxygen. (a) General. No person may operate...is provided with and uses supplemental oxygen for that part of the flight at...

2013-01-01

305

Prevalence of nutritional supplements in gyms  

Microsoft Academic Search

The abuse of all types of supplements to improve sport performance and physical fitness has spread to regularly gym users. The most appealing supplements are those that claim to help build muscle, improve endurance and reduce body fat. The aim of this study to evaluate the intake of nutritional and dietary supplements among males from four gyms in Kurukshetra, Haryana

Arvind Malik; Sonia Malik

2010-01-01

306

The use of dietary supplements by athletes  

Microsoft Academic Search

Many athletes use dietary supplements as part of their regular training or competition routine, including about 85% of elite track and field athletes. Supplements commonly used include vitamins, minerals, protein, creatine, and various “ergogenic” compounds. These supplements are often used without a full understanding or evaluation of the potential benefits and risks associated with their use, and without consultation with

Ronald J. Maughan; Frederic Depiesse; Hans Geyer

2007-01-01

307

Supplements of interest for sport-related injury and sources of supplement information among college athletes  

Microsoft Academic Search

Purpose: This study examined incidence of sport-related injury, interest in supplements to treat injury, and sources of supplement information among 145 college athletes (89 males, 56 females). Materials and methods: A survey was used to assess sport- related injuries, interest in three categories of supplements to treat injury, and sources of supplement information among college athletes who used athletic training

Malinauskas BM; Overton RF; Carraway VG; Cash BC

308

Omega-3 Fatty Acid Supplementation for the Treatment of Children with Attention-Deficit/Hyperactivity Disorder Symptomatology: Systematic Review and Meta-Analysis  

PubMed Central

Objective Several studies have demonstrated differences in omega-3 fatty acid composition in plasma and in erythrocyte membranes in patients with ADHD compared to unaffected controls. Omega-3 fatty acids have anti-inflammatory properties and can alter central nervous system cell membrane fluidity and phospholipid composition. Cell membrane fluidity can alter serotonin and dopamine neurotransmission. The goal of this meta-analysis is to examine the efficacy of omega-3 fatty acid supplementation in children with ADHD. Method We searched PubMED for randomized, placebo-controlled trials examining omega-3 fatty acid supplementation in children with ADHD symptomatology. Our primary outcome measure was standardized mean difference in rating scales of ADHD severity. We conducted secondary analyses to determine the effects of dosing of different omega-3 fatty acids in supplements. Results Ten trials involving 699 children were included in this meta-analysis. Omega-3 fatty acid supplementation demonstrated a small, but significant effect in improving ADHD symptoms. Eicosapentaenoic acid (EPA) dose within supplements was significantly correlated with supplement efficacy. We found no evidence of publication bias or heterogeneity between trials. Conclusion Omega-3 fatty acid supplementation, particularly with higher doses of EPA, was modestly effective in the treatment of ADHD. The relative efficacy of omega-3 fatty acid supplementation was modest compared to currently available pharmacotherapies for ADHD such as psychostimulants, atomoxetine or alpha-2 agonists. However, given its relatively benign side-effect profile and evidence of modest efficacy, it may be reasonable to use omega-3 fatty supplementation to augment traditional pharmacological interventions or for families who decline other psychopharmacological options.

Bloch, Michael H.; Qawasmi, Ahmad

2013-01-01

309

Research Experience for Teachers (RET) Supplement to Current NSF Awards  

NSF Publications Database

... of an REU Supplement request. For guidance concerning the RET Supplement, the Principal Investigator ... like to offer RET supplements in FY 2002 to CISE awardees. These supplements can be used for K-12 ...

310

Micronutrient and iron supplementation and effective antimalarial treatment synergistically improve childhood anaemia.  

PubMed

The control of childhood anaemia in malaria holoendemic areas is a major public health challenge for which an optimal strategy remains to be determined. Malaria prevention may compromise the development of partial immunity. Regular micronutrient supplementation has been suggested as an alternative but its effectiveness remains unsettled. We therefore conducted a randomised placebo-controlled intervention trial with 207 Tanzanian children aged 5 months to 3 years on the efficacy of supervised supplementation of low-dose micronutrients including iron (Poly Vi-Sol with iron) three times per week, with an average attendance of >/= 90%. The mean haemoglobin (Hb) level increased by 8 g/l more in children on supplement (95% CI 3-12) during the 5-month study. All age groups benefited from the intervention including severely anaemic subjects. The mean erythrocyte cell volume (MCV) increased but Hb in children >/= 24 months improved independently of MCV and no relation was found with hookworm infection. The data therefore suggest that micronutrients other than iron also contributed to Hb improvement. In the supplement group of children who had received sulfadoxine-pyrimethamine (SP) treatment, the mean Hb level increased synergistically by 22 g/l (95% CI 13-30) compared to 7 g/l (95% CI 3-10) in those without such treatment. Supplementation did not affect malaria incidence. In conclusion, micronutrient supplementation improves childhood anaemia in malaria holoendemic areas and this effect is synergistically enhanced by temporary clearance of parasitaemia. PMID:11044264

Ekvall, H; Premji, Z; Björkman, A

2000-10-01

311

A randomized controlled trial of preoperative oral supplementation with a specialized diet in patients with gastrointestinal cancer  

Microsoft Academic Search

Background & Aims: Perioperative nutrition with specialized enteral diets improves outcome when compared with standard formulas. A post-hoc analysis suggested preoperative administration as the most important period. Thus, we designed a study to understand prospectively whether preoperative supplementation could be as efficacious as the perioperative approach and superior to a conventional treatment (no artificial nutrition) in reducing postoperative infections and

Luca Gianotti; Marco Braga; Luca Nespoli; Giovanni Radaelli; Aldo Beneduce; Valerio Di Carlo

2002-01-01

312

Creatine Supplementation in Endurance Sports  

Microsoft Academic Search

Creatine (Cr) is a compound that is synthesized endogenously in the kidneys, liver, and pancreas by the transamidination and\\u000a subsequent transmethylation of three constituent amino acids: glycine, agrinine, and methionine (1). As a result of its amino acid origin, Cr can also be manufactured and consumed as a nutritional supplement. Consequently,\\u000a Cr is currently regarded as a true ergogenic aid,

Joel T. Cramer

313

Particle Suspension Mechanisms - Supplemental Material  

SciTech Connect

This supplemental material provides a brief introduction to particle suspension mechanisms that cause exfoliated skin cells to become and remain airborne. The material presented here provides additional context to the primary manuscript and serves as background for designing possible future studies to assess the impact of skin cells as a source of infectious aerosols. This introduction is not intended to be comprehensive and interested readers are encouraged to consult the references cited.

Dillon, M B

2011-03-03

314

Geoadditive Survival Models: A Supplement  

Microsoft Academic Search

This technical report supplements the paper Geoadditive Survival Models (Hennerfeind, Brezger and Fahrmeir, 2005, Revised for JASA). In particular, we describe the simulation study of this paper in greater detail, present additional results for the application, and provide a complete proof of Theorem 1, Corollary 1, as well as the lemmata and corollaries in the appendix. Here g0(t) = logf‚0(t)g

Andrea Hennerfeind; Andreas Brezger; Ludwig Fahrmeir

2005-01-01

315

Cardiovascular effects of calcium supplementation.  

PubMed

Trials in normal older women and in patients with renal impairment suggest that calcium supplements increase the risk of cardiovascular disease. To further assess their safety, we recently conducted a meta-analysis of trials of calcium supplements, and found a 27-31% increase in risk of myocardial infarction and a 12-20% increase in risk of stroke. These findings are robust because they are based on pre-specified analyses of randomized, placebo-controlled trials and show consistent risk across the trials. The fact that cardiovascular events were not primary endpoints of any of these studies will introduce noise but not bias into the data. A recent re-analysis of the Women's Health Initiative suggests that co-administration of vitamin D with calcium does not lessen these adverse effects. The increased cardiovascular risk with calcium supplements is consistent with epidemiological data relating higher circulating calcium concentrations to cardiovascular disease in normal populations. There are several possible pathophysiological mechanisms for these effects, including effects on vascular calcification, on the function of vascular cells, and on blood coagulation. Calcium-sensing receptors might mediate some of these effects. Because calcium supplements produce small reductions in fracture risk and a small increase in cardiovascular risk, there may be no net benefit from their use. Food sources of calcium appear to produce similar benefits on bone density, although their effects on fracture are unclear. Since food sources have not been associated with adverse cardiovascular effects, they may be preferable. Available evidence suggests that other osteoporosis treatments are still effective without calcium co-administration. PMID:21409434

Reid, I R; Bolland, M J; Avenell, A; Grey, A

2011-03-16

316

Teacher efficacy: A construct validation  

Microsoft Academic Search

Developed an instrument to measure teacher efficacy and examined the relationship between teacher efficacy and observable teacher behaviors. Factor analysis of responses from 208 elementary school teachers to a 30-item Teacher Efficacy Scale yielded 2 substantial factors that corresponded to A. Bandura's 2-factor theoretical model of self-efficacy. A multitrait–multimethod analysis that supported both convergent and discriminant validity analyzed data from

Sherri Gibson; Myron H. Dembo

1984-01-01

317

Bibliography of In-House and Contract Reports, Supplement 12.  

National Technical Information Service (NTIS)

This is Supplement 12 to the report titled 'Bibliography of In-House and Contract Reports' (AD-877 653L), (Supplement 1, AD-890 066L), (Supplement 2, AD-905 548L), (Supplement 3, AD-B005 275L), (Supplement 4, AD-B010 642L), (Supplement 5, AD-B019 966L), (...

R. P. Barron

1984-01-01

318

Bibliography of In-House and Contract Reports, Supplement 10.  

National Technical Information Service (NTIS)

This is Supplement 10 to the report titled 'Bibliography of In-House and Contract Reports,' (AD-877 653L), (Supplement 1, AD-890 066L), (Supplement 2, AD-905 548L), (Supplement 3, AD-B005 275L), (Supplement 4, AD-B010 642L), (Supplement 5, AD-B019 966L), ...

R. P. Barron M. F. Fox

1982-01-01

319

Bayesian estimation of vaccine efficacy  

Microsoft Academic Search

Protective vaccine efficacy, VES, is measured as one minus the incidence rate ratio (IRR) or the relative risk (RR) in the vaccinated group compared with the unvaccinated group. In this paper, we systematically present Bayesian estimation of protective vaccine efficacy based on the Poisson and binomial distributions. We also propose a new tool, the vaccine efficacy acceptability curve, to represent

Haitao Chu; M Elizabeth Halloran

2004-01-01

320

Tryptophan supplementation induces a positive bias in the processing of emotional material in healthy female volunteers  

Microsoft Academic Search

Rationale  The serotonin precursor l-tryptophan (TRP) is available as a nutritional supplement and is licensed as an antidepressant in a number of countries. However, evidence of its efficacy as the primary treatment for depression is limited, and the direct action of TRP on the symptoms of depression and anxiety has not been well-characterised.Objectives  The present study assessed whether TRP induces cognitive changes

Susannah E. Murphy; Calogero Longhitano; Rachael E. Ayres; Philip J. Cowen; Catherine J. Harmer

2006-01-01

321

Effect of routine iron supplementation with or without folic acid on anemia during pregnancy  

Microsoft Academic Search

Introduction  Iron deficiency is the most prevalent nutrient deficiency in the world, particularly during pregnancy. According to the literature,\\u000a anemia, particularly severe anemia, is associated with increased risk of maternal mortality. It also puts mothers at risk\\u000a of multiple perinatal complications. Numerous studies in the past have evaluated the impact of supplementation with iron and\\u000a iron-folate but data regarding the efficacy

Mohammad Yawar Yakoob; Zulfiqar A Bhutta

2011-01-01

322

Experience with long-term treatment with albumin-supplemented botulinum toxin type A  

Microsoft Academic Search

In earlier studies, we have demonstrated the efficacy of albumin-supplemented botulinum toxin type A (ASBTA) in principle.\\u000a Here, we present long-term data from 106 patients who received ASTBA over 5–10 years for the treatment of cervical dystonia,\\u000a blepharospasm and hemifacial spasm. Vials of Dysport® were diluted in 0.1% albumin solution to a concentration of 25 units\\/ml. Overall patients and indications, the mean

Bahram Mohammadi; Katja Kollewe; Maresa Wegener; Hans Bigalke; Reinhard Dengler

2009-01-01

323

Dietary supplementation with monosodium glutamate is safe and improves growth performance in postweaning pigs.  

PubMed

Dietary intake of glutamate by postweaning pigs is markedly reduced due to low feed consumption. This study was conducted to determine the safety and efficacy of dietary supplementation with monosodium glutamate (MSG) in postweaning pigs. Piglets were weaned at 21 days of age to a corn and soybean meal-based diet supplemented with 0, 0.5, 1, 2, and 4 % MSG (n = 25/group). MSG was added to the basal diet at the expense of cornstarch. At 42 days of age (21 days after weaning), blood samples (10 mL) were obtained from the jugular vein of 25 pigs/group at 1 and 4 h after feeding for hematological and clinical chemistry tests; thereafter, pigs (n = 6/group) were euthanized to obtain tissues for histopathological examinations. Feed intake was not affected by dietary supplementation with 0-2 % MSG and was 15 % lower in pigs supplemented with 4 % MSG compared with the 0 % MSG group. Compared with the control, dietary supplementation with 1, 2 and 4 % MSG dose-dependently increased plasma concentrations of glutamate, glutamine, and other amino acids (including lysine, methionine, phenylalanine and leucine), daily weight gain, and feed efficiency in postweaning pigs. At day 7 postweaning, dietary supplementation with 1-4 % MSG also increased jejunal villus height, DNA content, and antioxidative capacity. The MSG supplementation dose-dependently reduced the incidence of diarrhea during the first week after weaning. All variables in standard hematology and clinical chemistry tests, as well as gross and microscopic structures, did not differ among the five groups of pigs. These results indicate that dietary supplementation with up to 4 % MSG is safe and improves growth performance in postweaning pigs. PMID:23117836

Rezaei, Reza; Knabe, Darrell A; Tekwe, Carmen D; Dahanayaka, Sudath; Ficken, Martin D; Fielder, Susan E; Eide, Sarah J; Lovering, Sandra L; Wu, Guoyao

2012-11-02

324

Menopause: a review of botanical dietary supplements.  

PubMed

Since the release of the Women's Health Initiative (WHI) findings, an increasing number of dietary supplement products specifically targeting women in menopause have appeared in the American marketplace. This growth highlights the need for a critical evaluation of the tolerability and effectiveness of these products. The purpose of this article is to assess the evidence for safety and benefit of botanical monopreparations used for relief of menopause-related symptoms. The Cochrane Library and Medline databases were searched from January 1966 to October 2004, using a detailed list of terms related to botanicals and menopausal symptoms. Studies were considered eligible (1) if they were controlled trials of a botanical monopreparation administered orally for a minimum of 6 weeks to perimenopausal or postmenopausal women with hot flashes and (2) if they included a placebo or comparative treatment arm. Topical preparations, botanical combinations, and dietary interventions, such as soy food or protein, were not included. No language restrictions were imposed on the search. A total of 19 studies met the inclusion criteria. The majority of studies indicate that extract of black cohosh (Actaea racemosa L.) improves menopause-related symptoms; however, methodologic shortcomings in the trials were identified. To date, 4 case reports of possible hepatotoxicity have been published, although previous safety reviews suggest that black cohosh is well tolerated and that adverse events are rare when it is used appropriately. The results of 6 clinical studies on soy (Glycine max L.) isoflavone extracts are mixed. Moreover, the composition and dose of soy supplements varies widely across studies, making comparisons and definitive conclusions difficult. One study challenged the long-term safety of high-dose soy isoflavone extract (150 mg/day for 5 years) on the uterine endometrium. Clinical data from 5 controlled trials assessing the efficacy of semipurified isoflavone red clover (Trifolium pratense L.) leaf extracts to reduce hot flash frequency and severity or to relieve symptoms associated with the domains of the Greene Menopausal Symptom Scale are contradictory. The largest study showed no benefit for reducing symptoms associated with menopause for 2 different red clover isoflavone products compared with placebo. No significant adverse events have been reported in the literature. Single clinical trials do not support the use of dong quai (Angelica sinensis L.), ginseng (Panax ginseng C.A. Mey), or evening primrose seed oil (Oenothera biennis L.) for improving menopausal symptoms. We conclude that black cohosh extracts appear to ease menopausal symptoms; ongoing studies funded by the National Institutes of Health (NIH) will provide more definitive safety and efficacy data. Soy isoflavone extracts appear to have minimal to no effect, although definitive conclusions are difficult given the wide variation in product composition and dose. Long-term safety of higher dosage (150 mg/day) soy isoflavone extracts is uncertain. Semipurified isoflavone red clover leaf extracts have minimal to no effect in reducing menopausal symptoms. Dong quai, ginseng extract, and evening primrose seed oil appear to be ineffective in ameliorating menopausal symptoms at the dosages and in the preparations used in these studies. PMID:16414334

Low Dog, Tieraona

2005-12-19

325

Nutrition supplementation for diabetic wound healing: a systematic review of current literature.  

PubMed

There are 25.8 million people with diabetes in the United States (Centers for Disease Control and Prevention 2011 National Diabetes Fact Sheet). This number is expected to increase by 1 million per year. Diabetic foot ulcers (DFUs) occur in patients with a history of poorly controlled blood glucose. Almost 30% of people with diabetes aged 40 years or older experience DFUs caused by an impaired nerve sensation. It is one of the more persistent types of chronic wounds, which poses an economic burden on individuals and society and reduces the quality of life of patients and their families. This paper reviews the efficacy of nutrition supplementation in diabetic wound healing, including both human and animal studies. Using Preferred Reporting Items for Systematic Reviews and Meta-Analyses methods, the search was conducted in PubMed and ISI's Web of Science databases. Studies in which diabetic wounds/foot ulcers were treated with specific nutritional or herbal suplements were selected. This review includes 4 human and 9 animal studies that met the criteria of the search. Positive outcomes in the human studies were not significant while the nutritional supplements used in the animal studies were effective and promoted wound healing. The most notable effect of supplementation with curcumin, L-Arginine, or vitamin E have been shown in animal sudies. More human studies need to be conducted to determine the efficacy of these nutritional supplements in promoting wound healing. PMID:24053007

Maier, Haiyan M; Ilich, Jasminka Z; Kim, Jeong-Su; Spicer, Maria T

326

Hypertensive Retinopathy Associated With Use of the Ephedra-Free Weight-Loss Herbal Supplement Hydroxycut  

PubMed Central

The use of performance-enhancing and weight-loss supplements is prevalent in the United States, and over the past decade, there has been growing concern with regard to the safety and efficacy of these products. It is well documented that ephedra-based products are associated with adverse reactions, including serious cardiovascular and neurologic injuries. With new restrictions placed on such products, companies are now marketing caffeine-based ephedra-free herbal supplements. Less is known about the potential side effects of these products. We present the case of a 42-year-old, previously healthy man who developed malignant hypertension and hypertensive retinopathy while taking Hydroxycut, a caffeine-based ephedra-free supplement. To our knowledge, this is the first documented case of hypertensive retinopathy associated with the use of Hydroxycut. Given the lack of investigative studies in regard to their safety and efficacy, judicious care should be taken with the use of all herbal supplements, including those designated as ephedra-free. Readers are encouraged to respond to George Lundberg, MD, Editor of MedGenMed, for the editor's eye only or for possible publication via email: glundberg@medscape.net

Willis, Scott L.; Moawad, Fouad J.; Hartzel, Joshua D.; Iglesias, Melissa; Jackson, William L.

2006-01-01

327

Modeling Efficacy: The Effect of Perceived Parental Efficacy on the Self-Efficacy of Early Adolescents  

Microsoft Academic Search

This study examines the effects of early adolescents' perceptions of parents' efficacy and parents' behaviors on the self-efficacy of early adolescents. Eighty-two young people between the ages of 9 and 15 years provided data on themselves and their parents in structured interviews. Separate path analyses for same and opposite sex parents for boys and girls provide evidence that perceived efficacy

Les B. Whitbeck

1987-01-01

328

Effects of Chromium Brewer’s Yeast Supplementation on Body Mass, Blood Carbohydrates, and Lipids and Minerals in Type 2 Diabetic Patients  

Microsoft Academic Search

Chromium(III) is considered as an essential element for carbohydrate and lipid metabolism. The aim of this clinical study\\u000a was to evaluate the efficacy of Cr brewer’s yeast supplementation on body mass, carbohydrate, lipids and mineral indices in\\u000a type 2 diabetic patients. Twenty adult type 2 diabetic subjects (11 males and 9 females aged 37–63) were supplemented with\\u000a Cr brewer’s yeast

Ewelina Król; Zbigniew Krejpcio; Hanna Byks; Pawe? Bogda?ski; Danuta Pupek-Musialik

329

Dietary supplement use and medical conditions  

Microsoft Academic Search

BackgroundOver half of U.S. adults use vitamin or mineral supplements, and some are likely using supplements to treat chronic diseases or risk factors for disease. Information on the relationship between supplement use and medical conditions is useful to health professionals to understand the self-medication behavior of their patients, and important for researchers because medical conditions may be potential confounding factors

Jessie Satia-Abouta; Alan R Kristal; Ruth E Patterson; Alyson J Littman; Kayla L Stratton; Emily White

2003-01-01

330

Nutritional Supplements for Strength Power Athletes  

Microsoft Academic Search

\\u000a Over the last decade research involving nutritional supplementation and sport performance has increased substantially. Strength\\u000a and power athletes have specific needs to optimize their performance. Nutritional supplementation cannot be viewed as a replacement\\u000a for a balanced diet but as an important addition to it. However, diet and supplementation are not mutually exclusive, nor\\u000a does one depend on the other. Strength

Colin Wilborn

2008-01-01

331

Effect of betaine supplementation on power performance and fatigue  

PubMed Central

Background The purpose of this study was to examine the efficacy of 15 days of betaine supplementation on muscle endurance, power performance and rate of fatigue in active college-aged men. Methods Twenty-four male subjects were randomly assigned to one of two groups. The first group (BET; 20.4 ± 1.3 years; height: 176.8 ± 6.6 cm; body mass: 77.8 ± 13.4 kg) consumed the supplement daily, and the second group (PL; 21.4 ± 4.7 years; height: 181.3 ± 5.9 cm; body mass: 83.3 ± 5.2 kg) consumed a placebo. Subjects were tested prior to the onset of supplementation (T1) and 7 (T2) and 14 days (T3) following supplementation. Each testing period occurred over a 2-day period. During day one of testing subjects performed a vertical jump power (VJP) and a bench press throw (BPT) power test. In addition, subjects were required to perform as many repetitions as possible with 75% of their 1-RM in both the squat and bench press exercises. Both peak and mean power was assessed on each repetition. On day two of testing subjects performed two 30-sec Wingate anaerobic power tests (WAnT), each test separated by a 5-min active rest. Results No differences were seen at T2 or T3 in the repetitions performed to exhaustion or in the number of repetitions performed at 90% of both peak and mean power between the groups in the bench press exercise. The number of repetitions performed in the squat exercise for BET was significantly greater (p < 0.05) than that seen for PL at T2. The number of repetitions performed at 90% or greater of peak power in the squat exercise was significantly greater for BET at both T2 and T3 than PL. No differences in any power assessment (VJP, BPT, WAnT) was seen between the groups Conclusion Two-weeks of betaine supplementation in active, college males appeared to improve muscle endurance of the squat exercise, and increase the quality of repetitions performed.

Hoffman, Jay R; Ratamess, Nicholas A; Kang, Jie; Rashti, Stefanie L; Faigenbaum, Avery D

2009-01-01

332

Nutritional supplements as radioprotectors -- A review and proposal  

SciTech Connect

The scientific literature contains several reports that show nutritional substances, such as vitamins, minerals, and phytochemicals (plant chemicals), provide substantial radioprotective effects in animal studies. Incorporating these substances to the human diet, already voluntarily practiced by a large segment of the population, in addition to providing other favorable health effects, may also provide a radioprotective effect. This potential radioprotective effect would be very useful in mitigating the effects of occupational radiation exposure to astronauts (especially future Mars explorers), airline crews, nuclear workers, both commercial and government, and populations exposed to nuclear accidents, e.g. Chernobyl. This paper reviews the existing evidence of radioprotective effects by nutritional supplements and proposes that their efficacy be evaluated, first with animal studies, followed by human tests with astronauts and cosmonauts on long-term missions, such as to the Mir space station and the International Space Station (ISS).

Muscatello, A.C.

1998-12-31

333

The Regulation and Expression of the Creatine Transporter: A Brief Review of Creatine Supplementation in Humans and Animals  

PubMed Central

Creatine monohydrate has become one of the most popular ergogenic sport supplements used today. It is a nonessential dietary compound that is both endogenously synthesized and naturally ingested through diet. Creatine ingested through supplementation has been observed to be absorbed into the muscle exclusively by means of a creatine transporter, CreaT1. The major rationale of creatine supplementation is to maximize the increase within the intracellular pool of total creatine (creatine + phosphocreatine). There is much evidence indicating that creatine supplementation can improve athletic performance and cellular bioenergetics, although variability does exist. It is hypothesized that this variability is due to the process that controls both the influx and efflux of creatine across the cell membrane, and is likely due to a decrease in activity of the creatine transporter from various compounding factors. Furthermore, additional data suggests that an individual's initial biological profile may partially determine the efficacy of a creatine supplementation protocol. This brief review will examine both animal and human research in relation to the regulation and expression of the creatine transporter (CreaT). The current literature is very preliminary in regards to examining how creatine supplementation affects CreaT expression while concomitantly following a resistance training regimen. In conclusion, it is prudent that future research begin to examine CreaT expression due to creatine supplementation in humans in much the same way as in animal models.

Schoch, Ryan D; Willoughby, Darryn; Greenwood, Mike

2006-01-01

334

The regulation and expression of the creatine transporter: a brief review of creatine supplementation in humans and animals.  

PubMed

Creatine monohydrate has become one of the most popular ergogenic sport supplements used today. It is a nonessential dietary compound that is both endogenously synthesized and naturally ingested through diet. Creatine ingested through supplementation has been observed to be absorbed into the muscle exclusively by means of a creatine transporter, CreaT1. The major rationale of creatine supplementation is to maximize the increase within the intracellular pool of total creatine (creatine + phosphocreatine). There is much evidence indicating that creatine supplementation can improve athletic performance and cellular bioenergetics, although variability does exist. It is hypothesized that this variability is due to the process that controls both the influx and efflux of creatine across the cell membrane, and is likely due to a decrease in activity of the creatine transporter from various compounding factors. Furthermore, additional data suggests that an individual's initial biological profile may partially determine the efficacy of a creatine supplementation protocol. This brief review will examine both animal and human research in relation to the regulation and expression of the creatine transporter (CreaT). The current literature is very preliminary in regards to examining how creatine supplementation affects CreaT expression while concomitantly following a resistance training regimen. In conclusion, it is prudent that future research begin to examine CreaT expression due to creatine supplementation in humans in much the same way as in animal models. PMID:18500965

Schoch, Ryan D; Willoughby, Darryn; Greenwood, Mike

2006-06-23

335

47 CFR 87.347 - Supplemental eligibility.  

Code of Federal Regulations, 2012 CFR

...SERVICES AVIATION SERVICES Aeronautical Utility Mobile Stations ...Supplemental eligibility. (a) Aeronautical utility stations may transmit... (b) An applicant for an aeronautical utility station operating...

2012-10-01

336

47 CFR 87.277 - Supplemental eligibility.  

Code of Federal Regulations, 2012 CFR

...COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES Aeronautical Enroute and Aeronautical Fixed Stations Aeronautical Fixed Stations § 87.277 Supplemental eligibility. Aeronautical fixed...

2012-10-01

337

47 CFR 87.277 - Supplemental eligibility.  

Code of Federal Regulations, 2011 CFR

...COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES Aeronautical Enroute and Aeronautical Fixed Stations Aeronautical Fixed Stations § 87.277 Supplemental eligibility. Aeronautical fixed...

2011-10-01

338

47 CFR 87.347 - Supplemental eligibility.  

Code of Federal Regulations, 2011 CFR

...SERVICES AVIATION SERVICES Aeronautical Utility Mobile Stations ...Supplemental eligibility. (a) Aeronautical utility stations may transmit... (b) An applicant for an aeronautical utility station operating...

2011-10-01

339

Herbal and dietary supplement hepatotoxicity.  

PubMed

Herbal and dietary supplements (HDS) are commonly used in the United States and throughout the world. The Dietary Supplement Health and Education Act and public standards set through the U.S. Pharmacopeia provide regulatory framework for these products. These regulations help to ensure the safety of grandfathered and new HDS coming onto the market, and the opportunity to identify and take action against unsafe products that have been distributed. The clinical patterns of presentation and severity of HDS-associated hepatotoxicity can be highly variable, even for the same product. In addition, accurate causality assessment in cases of suspected HDS hepatotoxicity is confounded by infrequent ascertainment of product intake by healthcare providers, under-reporting of HDS use by patients, the ubiquity of HDS and the complexity of their components, and the possibility for product adulteration. Additional measures to prevent HDS-induced hepatotoxicity include greater consumer and provider awareness, increased spontaneous reporting, and reassessment of regulations regarding the manufacturing, distribution, and marketing of these products. PMID:19826971

Navarro, Victor J

2009-10-13

340

Lactoferrin supplementation to dairy calves.  

PubMed

Twenty-one Holstein calves (12 bulls, 9 heifers) were used to evaluate the effects of supplemental lactoferrin (0, 1, and 10 g/d) added to colostrum, milk, and milk replacer in a 56-d study. Calves fed lactoferrin (LF) weighed more during wk 2, 3, 4, 5, and 6 than control calves. Calves fed LF had increased preweaning daily weight gains and heart girth gains compared with calves not fed lactoferrin. Calves fed 1 g/d LF had a greater preweaning average daily gain than calves fed 10 g/d of lactoferrin. Hematocrit and serum Fe were unaffected by treatments. Calves were weaned when they had consumed 0.7 kg of calf starter grain for 2 consecutive d and were at least 28 d of age. All calves were weaned by 35 d of age, regardless of starter intake. Calves fed LF consumed more calf starter grain during the preweaning period and met weaning criteria at a younger age. This study indicates that supplementing calf diets with LF is advantageous to calf performance. PMID:12086060

Joslin, R S; Erickson, P S; Santoro, H M; Whitehouse, N L; Schwab, C G; Rejman, J J

2002-05-01

341

Dietary Supplement Ingredient Database (DSID): New Tool for Assessing Nutrient Intake from Dietary Supplements  

Technology Transfer Automated Retrieval System (TEKTRAN)

Accurate information on the nutrient composition of dietary supplements is essential for determining their contribution to dietary intake. This year, the preliminary release of dietary supplement composition information is now available for researchers' use in evaluating diet and health interrelatio...

342

Effect of postoperative supplemental oxygen on nausea and vomiting after cesarean birth.  

PubMed

Postoperative nausea and vomiting (PONV) has a significant impact on patients and health care providers. Some nonpharmacologic methods may have an effect on PONV. Administration of supplemental oxygen (80%) during and for 2 hours after surgery has been shown to reduce the incidence of PONV from 44% to 22%. However, the effect of limiting supplemental oxygen to the immediate postoperative period on PONV is unknown. The purpose of this study was to test the efficacy of postoperative supplemental oxygen in reducing the incidence of PONV. Patients (n = 106) undergoing cesarean birth were given general anesthesia with 50% oxygen balanced nitrous oxide and in the postoperative period were randomly assigned to 2 groups. Patients in the experimental group received 8 L/min oxygen by a simple face mask for 6 hours. The control group received routine care of oxygen 5 L/min in the PACU and no supplemental oxygen on the ward. Trained nurses evaluated pulse oximetry and PONV after surgery. The incidence of PONV during the first 6 postoperative hours was 28.3% in the experimental group and 24.5% in the control group ( P = .659). There was no statistically significant difference between the 2 groups. In this study, postoperative supplemental oxygen 8 L/min did not prevent PONV in patients undergoing cesarean birth. PMID:15933967

Ghods, Ali Asghar; Soleimani, Mohsen; Narimani, Mahnaz

2005-06-01

343

Interactions of commonly used dietary supplements with cardiovascular drugs: a systematic review  

PubMed Central

Background The objective of this systematic review was to examine the benefits, harms and pharmacokinetic interactions arising from the co-administration of commonly used dietary supplements with cardiovascular drugs. Many patients on cardiovascular drugs take dietary supplements for presumed benefits and may be at risk for adverse supplement-drug interactions. Methods The Allied and Complementary Medicine Database, the Cochrane Library, EMBASE, International Bibliographic Information on Dietary Supplements and MEDLINE were searched from the inception of the review to October 2011. Grey literature was also reviewed. Two reviewers independently screened records to identify studies comparing a supplement plus cardiovascular drug(s) with the drug(s) alone. Reviewers extracted data using standardized forms, assessed the study risk of bias, graded the strength of evidence and reported applicability. Results Evidence was obtained from 65 randomized clinical trials, 2 controlled clinical trials and 1 observational study. With only a few small studies available per supplement, evidence was insufficient for all predefined gradable clinical efficacy and harms outcomes, such as mortality and serious adverse events. One long-term pragmatic trial showed no benefit from co-administering vitamin E with aspirin on a composite cardiovascular outcome. Evidence for most intermediate outcomes was insufficient or of low strength, suggesting no effect. Incremental benefits were noted for triglyceridemia with omega-3 fatty acid added to statins; and there was an improvement in levels of high-density lipoprotein cholesterol with garlic supplementation when people also consumed nitrates Conclusions Evidence of low-strength indicates benefits of omega-3 fatty acids (plus statin, or calcium channel blockers and antiplatelets) and garlic (plus nitrates or warfarin) on triglycerides and HDL-C, respectively. Safety concerns, however, persist.

2012-01-01

344

The Efficacy of Psychodynamic Psychotherapy  

Microsoft Academic Search

Empirical evidence supports the efficacy of psychodynamic therapy. Effect sizes for psychodynamic psychotherapy are as large as those reported for other therapies that have been actively promoted as \\

Jonathan Shedler

2009-01-01

345

Mechanisms of muscular adaptations to creatine supplementation  

Microsoft Academic Search

Creatine supplementation is a widely used and heavily studied ergogenic aid. Athletes use creatine to increase muscle mass, strength, and muscle endurance. While the performance and muscle- building effects of creatine supplementation have been well documented, the mechanisms responsible for these muscular adaptations have been less studied. Objective: The purpose of this review is to examine studies of the mechanisms

Eric S Rawson; Adam M Persky

2007-01-01

346

Nutritional claims for functional foods and supplements  

Microsoft Academic Search

Food labels are an important educational tool to assist consumers in making healthy food choices. In addition to mandatory nutritional labeling information, manufacturers have a variety of options on the food\\/supplement packages to communicate the nutrition\\/health benefits of their products. This paper describes the different types of claims that can be made for foods and supplements.

Sanjiv Agarwal; Stein Hordvik; Sandra Morar

2006-01-01

347

Enhanced Nutrition Education Instead of Consuming Supplements  

ERIC Educational Resources Information Center

|Fueled by the internet, instantaneous videos, and the emphasis to look "right" or always win athletic competitions, many students are seeking information on nutrition and dietary supplements. Classroom observations reveal student interest and discussions are among the highest when the topic is dietary supplements. Teachers and coaches provide an…

Crowder, Todd; Kidd, Kellie; Jensen, Nancy; Jensen, Laura

2008-01-01

348

Journal Supplements Focused on Physical Activity Measurement  

Cancer.gov

This journal supplement summarizes and builds upon a workshop which convened researchers from diverse sectors and organizations to critically review the state-of-the-science. The supplement discusses current technologies for objective physical activity monitoring, provides recommendations for the use of these technologies, and explores future directions in the development of new tools and approaches.

349

Dietary soy supplementation and phytoestrogen levels  

Microsoft Academic Search

Objective: To investigate the relationship between levels of phytoestrogens in blood and urine and symptom control in postmenopausal women whose diets were supplemented with soy containing high levels of phytoestrogen.Methods: Phytoestrogen levels in blood and urine were correlated with the number of hot flushes and vaginal maturation indices in 104 postmenopausal women whose diets were supplemented with 60 g of

P Albertazzi; F Pansini; M Bottazzi; G Bonaccorsi; D De Aloysio; M. S Morton

1999-01-01

350

Effect of molasses supplementation on ruminal fermentation  

Technology Transfer Automated Retrieval System (TEKTRAN)

This fact sheet summarizes the results of two continuous culture fermentor studies that evaluated the effects of molasses supplementation on ruminal fermentation of a pasture diet. The first study compared molasses with corn supplementation. Diets consisted of pasture only, molasses plus pasture, co...

351

CURRENT PATTERNS OF SUPPLEMENT USE IN ADOLESCENTS  

Technology Transfer Automated Retrieval System (TEKTRAN)

Many adults take vitamin mineral supplements, but there is relatively little up-to-date information available on vitamin-mineral supplement use among adolescents. In the 1998 Child and Adolescent Trial for Cardiovascular Health Tracking Study (CATCH III), a school-based dietary intervention sponsor...

352

21 CFR 814.39 - PMA supplements.  

Code of Federal Regulations, 2010 CFR

...Drugs 8 2009-04-01 2009-04-01 false PMA supplements. 814.39 Section 814.39 Food and...OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.39 PMA supplements. (a) After FDA's approval of a...

2009-04-01

353

21 CFR 814.39 - PMA supplements.  

Code of Federal Regulations, 2010 CFR

...Drugs 8 2010-04-01 2010-04-01 false PMA supplements. 814.39 Section 814.39 Food and...OF MEDICAL DEVICES Premarket Approval Application (PMA) § 814.39 PMA supplements. Link to an amendment published at...

2010-04-01

354

Vitamin and mineral supplementation and exercise performance  

Microsoft Academic Search

Summary Supplements of vitamins C and E have shown promise in reducing exercise-related symptoms (delayed muscle soreness) and bio- chemical indices of oxidative stress in both trained and untrained individuals. However, these antioxidant supplements appear to have no beneficial effect on performance and more research is needed to prove their long-term use is safe and effective. A prudent recommendation for

Michael B. Zimmermann

355

Supplement consumption in body builder athletes  

PubMed Central

BACKGROUND: Widespread use of supplements is observed among world athletes in different fields. The aim of this study was to estimate the prevalence and determinants of using supplements among body builder athletes. METHODS: This cross-sectional study was conducted on 250 men and 250 women from 30 different bodybuilding clubs. Participants were asked to complete a self-administered standardized anonymous check-list. RESULTS: Forty nine percent of the respondents declared supplement use. Men were more likely to take supplements than women (86.8% vs. 11.2%, p = 0.001). Reasons for using supplements were reported to be for health (45%), enhancing the immune system (40%) and improving athletic performance (25%). Most athletes (72%) had access to a nutritionist but underused this resource. Coaches (65%) had the greatest influence on supplementation practices followed by nutritionists (30%) and doctors (25%) after them. CONCLUSIONS: The prevalence of supplement use among bodybuilders was high. Sex, health-related issues and sport experts were determinant factors of supplement use.

Karimian, Jahangir; Esfahani, Parivash Shekarchizadeh

2011-01-01

356

CURRENT POPULATION SURVEY MARRIAGE AND FERTILITY SUPPLEMENT  

EPA Science Inventory

These supplements to the June round of the Current Population Survey (conducted at five-year intervals starting in 1971) were designed to examine transitions in the American family and to measure the demographic implications of these transitions for children. The supplements ask ...

357

Compliance Supplement. OMB Circular A-133.  

ERIC Educational Resources Information Center

|This document is a supplement to Circular A-133 (1990) from the Office of Management and Budget (OMB), which extended the government's "single audit process" for agencies that administer federal financial assistance programs to higher education institutions and non-profit organizations. This supplement is based on the 1996 Amendments (the Single…

Office of Management and Budget, Washington, DC.

358

Effect of prenatal zinc supplementation on birthweight.  

PubMed

Although iron and zinc deficiencies are known to occur together and also appear to be high in Ghana, a few supplementation studies addressed this concurrently in pregnancy. In a double-blind, randomized controlled trial, 600 pregnant women in Ghana were randomly assigned to receive either a combined supplement of 40 mg of zinc as zinc gluconate and 40 mg of iron as ferrous sulphate or 40 mg of elemental iron as ferrous sulphate. Overall, there was no detectable difference in the mean birthweight between the study groups, although the effect of iron-zinc supplementation on the mean birthweight was masked by a strong interaction between the type of supplement and the iron status of participants [F (1,179) = 5.614, p = 0.019]. Prenatal iron-zinc supplementation was effective in increasing the mean birthweight among anaemic and iron-deficient women but not among women with elevated iron stores in early pregnancy. PMID:19902797

Saaka, Mahama; Oosthuizen, Jacques; Beatty, Shelley

2009-10-01

359

Regional Assessment of Supplementation Project. Status report  

SciTech Connect

The Fish and Wildlife Program of the Northwest Power Planning Council (NPPC) prescribes several approaches to achieve its goal of doubling the salmon and steelhead runs of the Columbia River. Among those approaches are habitat restoration, improvements in adult and juvenile passage at dams and artificial propagation. Supplementation will be a major part of the new hatchery programs. The purpose of the Regional Assessment of Supplementation Project (RASP) is to provide an overview of ongoing and planned supplementation activities, to construct a conceptual framework and model for evaluating the potential benefits and risks of supplementation and to develop a plan for better regional coordination of research and monitoring and evaluation of supplementation. RASP has completed its first year of work. Progress toward meeting the first year`s objectives and recommendations for future tasks are contained in this report.

Not Available

1991-10-01

360

Effect of Prenatal Zinc Supplementation on Birthweight  

PubMed Central

Although iron and zinc deficiencies are known to occur together and also appear to be high in Ghana, a few supplementation studies addressed this concurrently in pregnancy. In a double-blind, randomized controlled trial, 600 pregnant women in Ghana were randomly assigned to receive either a combined supplement of 40 mg of zinc as zinc gluconate and 40 mg of iron as ferrous sulphate or 40 mg of elemental iron as ferrous sulphate. Overall, there was no detectable difference in the mean birthweight between the study groups, although the effect of iron-zinc supplementation on the mean birthweight was masked by a strong interaction between the type of supplement and the iron status of participants [F (1,179)=5.614, p=0.019]. Prenatal iron-zinc supplementation was effective in increasing the mean birthweight among anaemic and iron-deficient women but not among women with elevated iron stores in early pregnancy.

Oosthuizen, Jacques; Beatty, Shelley

2009-01-01

361

The Efficacy of Medical Nutrition Therapy on Anthropometric Parameters in HIV\\/AIDs Clients in a Community Setting  

Microsoft Academic Search

HIV\\/AIDS is one of the most challenging interventions a medical nutrition therapist will approach. Premorbidity, metabolic complications and wasting complicate and compromise nutrition status. The efficacy of whether early nutrition intervention by providing food, nutrition education and supplementation stop the trends toward wasting\\/complications was studied. Clients received nutrition assessment to determine nutritional risk, and were placed in nutritional risk categories

Anthony S. Beard; Michele Z. Trnavsky

1998-01-01

362

The treatment of hypercholesterolemic children: Efficacy and safety of a combination of red yeast rice extract and policosanols  

Microsoft Academic Search

Background and aimsThe prevention of cardiovascular risk, as occurs in lipoprotein disorders, is required since childhood. Aim of the study was to evaluate, in a group of children affected by primary dyslipidemia, the efficacy, tolerability and safety of a short-term treatment with a dietary supplement containing red yeast rice extract and policosanols.

O. Guardamagna; F. Abello; V. Baracco; B. Stasiowska; F. Martino

2011-01-01

363

Epistemological Beliefs and Teacher Efficacy  

ERIC Educational Resources Information Center

|The purpose of this study was to determine if the strength of teachers' epistemological beliefs predicted variance in teachers' sense of efficacy. Specifically, the study sought to determine the extent to which beliefs in Certain Knowledge and Omniscient Authority accounted for variability in general teaching efficacy, over and above that…

Fernandez, Griffin W.

2009-01-01

364

Teacher Efficacy Measurement and Change.  

ERIC Educational Resources Information Center

|Research on the concept of teacher efficacy spans over 20 years, but much remains to be learned. Although precise definitions of the concept have always been problematic, in general, teacher efficacy is defined as teacher's belief or conviction that they can influence how well students learn (T. Guskey and P. Passaro, 1994). Efforts to clarify…

Guskey, Thomas R.

365

Efficacy of Office Ergonomics Education  

Microsoft Academic Search

The incidence of musculoskeletal injuries associated with computer use is increasing. Education has been advocated as a prevention method for reducing the incidence and severity of these injuries. Although the inclusion of education in prevention programs has become a popular practice, its efficacy is poorly defined. The present study was designed to investigate the efficacy of worker education programs in

Paula C. Bohr

2000-01-01

366

Overview of the August 2008 CPS Migration Supplement.  

National Technical Information Service (NTIS)

In August 2008, the U.S. Census Bureau sponsored a supplement to the monthly Current Population Survey (CPS) questionnaire. The Immigration/Emigration Supplement, also referred to as the Migration Supplement, included questions on five topics citizenship,...

E. M. Grieco G. Patricia de la Cruz L. J. Larsen

2012-01-01

367

MedlinePlus: Drugs, Herbs and Supplements: MedlinePlus  

MedlinePLUS

... approved labels included in drug packages, see DailyMed . Herbs and Supplements Browse dietary supplements and herbal remedies ... their effectiveness, usual dosage, and drug interactions. All herbs and supplements Prescription and over-the-counter medication ...

368

21 CFR 884.6180 - Reproductive media and supplements.  

Code of Federal Regulations, 2013 CFR

... 2013-04-01 false Reproductive media and supplements. 884.6180 Section...Reproduction Devices § 884.6180 Reproductive media and supplements. (a) Identification. Reproductive media and supplement are products that are...

2013-04-01

369

49 CFR 520.31 - Amendments or supplements.  

Code of Federal Regulations, 2011 CFR

...DEPARTMENT OF TRANSPORTATION PROCEDURES FOR CONSIDERING ENVIRONMENTAL IMPACTS Procedures § 520.31 Amendments or supplements. A draft or final environmental impact statement may be amended or supplemented. Supplements or amendments...

2011-10-01

370

49 CFR 520.31 - Amendments or supplements.  

Code of Federal Regulations, 2012 CFR

...DEPARTMENT OF TRANSPORTATION PROCEDURES FOR CONSIDERING ENVIRONMENTAL IMPACTS Procedures § 520.31 Amendments or supplements. A draft or final environmental impact statement may be amended or supplemented. Supplements or amendments...

2012-10-01

371

20 CFR 416.2030 - Optional supplementation: Variations in payments.  

Code of Federal Regulations, 2010 CFR

...Optional supplementation: Variations in payments. 416.2030 Section 416.2030 Employees' Benefits SOCIAL SECURITY ADMINISTRATION...Supplementation Provisions; Agreement; Payments § 416.2030 Optional supplementation: Variations in...

2009-04-01

372

7 CFR 372.10 - Supplementing environmental impact statements.  

Code of Federal Regulations, 2013 CFR

...2013-01-01 false Supplementing environmental impact statements. 372.10...372.10 Supplementing environmental impact statements. Once a decision to supplement an environmental impact statement is made, a...

2013-01-01

373

The Case for Reconceptualizing Teacher Efficacy Research  

ERIC Educational Resources Information Center

|This paper explores possible uses of teacher efficacy research by democratic teacher educators. The many possible meanings of teacher efficacy levels make it problematic for teacher educators to interpret and use teacher efficacy. Beneficial teacher efficacy doubts and problematic types of teacher efficacy confidence are identified, including…

Wheatley, K.F.

2005-01-01

374

15 CFR 921.31 - Supplemental acquisition and development awards.  

Code of Federal Regulations, 2013 CFR

...NATIONAL ESTUARINE RESEARCH RESERVE SYSTEM REGULATIONS...Supplemental acquisition and development awards. After National Estuarine Research Reserve designation...National Estuarine Research Reserve for supplemental development costs directly...

2013-01-01

375

10 CFR 1021.314 - Supplemental environmental impact statements.  

Code of Federal Regulations, 2013 CFR

...2013-01-01 false Supplemental environmental impact statements. 1021.314...GENERAL PROVISIONS) NATIONAL ENVIRONMENTAL POLICY ACT IMPLEMENTING PROCEDURES...1021.314 Supplemental environmental impact statements. (a)...

2013-01-01

376

Case of acute psychosis from herbal supplements.  

PubMed

A recent study estimates that 15.2 percent of American adults use nonprescription dietary supplements for weight loss. Sale of ephedrine- and ephedrine-alkaloid-containing products was prohibited by the Food and Drug Administration in February 2004 after research demonstrated an increased risk of arrhythmia, mortality and hypertension following use of products containing these sympathomimetics. Subsequently, nutritional supplement manufacturers have turned to other products to promote weight loss. The following paper reports a case study of a 28-year-old woman with no prior psychiatric history who was hospitalized secondary to an acute psychotic episode. The patient reported starting several weight-loss and nutritional sports supplements approximately one week prior to admission. The relationship between the onset of psychosis and the initiation of the dietary supplements strongly suggests a correlation exists. Heightened consumer education regarding the contents of dietary supplements, along with their potential for causing adverse effects when used alone or in combination with other medications, is warranted. Patients who choose to take dietary supplements should be encouraged to inform their health care providers about the supplements they are taking. PMID:18630028

Peterson, Erica; Stoebner, Adam; Weatherill, Jay; Kutscher, Eric

2008-05-01

377

Infliximab: Efficacy in psoriasis.  

PubMed

Moderate to severe psoriasis often needs to be addressed with standard disease modifying therapies such as methotrexate, cyclosporine, acitretin or ultraviolet radiation, which have their potential benefits and limitations. The tumor necrosis factor-alpha (TNF-?) is elevated in psoriatic plaques compared to non lesional skin as well as in the plasma of patients with moderate to severe psoriasis. Infliximab, a TNF-? blocker, has been recommended for the treatment of moderate to severe plaque psoriasis in adults who have failed to respond to these therapies or who cannot tolerate them. Its specific action on the bound and membrane forms of the pro-inflammatory cytokine TNF-? has made it the molecule of choice for obtaining quicker and longer remission in recalcitrant cases. However, the widespread use of infliximab in the Indian subcontinent is limited by its cost. This article reviews the international guidelines for use of infliximab, its dosage patterns, and efficacy in chronic plaque psoriasis, nail psoriasis, erythrodermic psoriasis, and pustular psoriasis as well as Indian experience. PMID:23974692

Arsiwala, Shehnaz

2013-07-01

378

IMAP statement on contraceptive efficacy.  

PubMed

Unwanted pregnancy may have serious negative effects upon the health and well-being of individuals and families. The use of effective contraception is therefore important. Efficacy, however, is not the only factor considered by clients when choosing a contraceptive method, so counsellors and service providers should not promote methods on the sole basis of their efficacy, irrespective of client preference. With regard to method efficacy, important considerations which may affect the choice of a method are the availability of emergency contraception and access to safe abortion services in the event of method failure. Biological factors such as age, parity, and whether a woman is breast feeding may affect contraceptive efficacy and should be a consideration when choosing a method. Contraceptive efficacy is usually measured in terms of failure rates calculated from the number of pregnancies which occur during a specified period of contraceptive use. Method failure is that attributable to the method, while user failure is that attributable to incorrect use of the method in addition to method failure. The failure rates for specific methods of contraception reported in the literature vary, sometimes substantially. The article briefly considers the measurement of efficacy and human factors affecting contraceptive efficacy with regard to clients, providers, and managers. PMID:12319092

1994-08-01

379

Effect of Supplemental Antioxidants Vitamin C, Vitamin E, and Coenzyme Q10 for the Prevention and Treatment of Cardiovascular Disease. Evidence Report/Technology Assessment Number 83.  

National Technical Information Service (NTIS)

The purpose of this study was to conduct a systematic review of the scientific literature to identify and assess the evidence for the efficacy of the antioxidant supplements vitamin C, vitamin E, and coenzyme Q10 for the prevention and treatment of cardio...

2003-01-01

380

Over-the-Counter Medication and Herbal or Dietary Supplement Use in College: Dose Frequency and Relationship to Self-Reported Distress  

ERIC Educational Resources Information Center

Objective: A growing number of researchers have examined the use of over-the-counter (OTC) medications and herbal or dietary supplements among college students. There is concern about the efficacy and safety of these products, particularly because students appear to use them at a higher rate than does the general public. Participants and Methods:…

Stasio, Michael J.; Curry, Kim; Sutton-Skinner, Kelly M.; Glassman, Destinee M.

2008-01-01

381

Important considerations for treatment with dietary supplement versus prescription niacin products.  

PubMed

Niacin is a water-soluble B vitamin (B3) known to have favorable effects on multiple lipid parameters, including raising high-density lipoprotein cholesterol (HDL-C) levels and lowering triglycerides (TGs), lipoprotein(a), and low-density lipoprotein cholesterol (LDL-C). Although LDL-C remains the primary target of lipid-altering therapy, current guidelines emphasize HDL-C and other modifiable lipid factors as key secondary targets. Thus, niacin is considered an important therapeutic option to help reduce the risk of cardiovascular disease in patients with mixed dyslipidemia who, in addition to high LDL-C, have elevated TGs and low HDL-C. Although available prescription niacin products, including immediate-release niacin (IR; Niacor) and an extended-release niacin formulation (Niaspan), have demonstrated safety and efficacy in randomized clinical trials, confusion remains among health care providers and their patients regarding the various commercially available nonprescription dietary supplement niacin products. These dietary supplements, which include IR, sustained-release (SR), and "no-flush" or "flush-free" niacin products, are not subject to the same stringent US Food and Drug Administration regulations as prescription drugs. In fact, both the American Heart Association and the American Pharmacists Association recommend against the use of dietary supplement niacin as a substitute for prescription niacin. Although some dietary supplement IR and SR niacin products have demonstrated a lipid response in clinical trials, products labeled as "no-flush" or "flush-free" that are intended to avoid the common niacin-associated adverse effect of flushing generally contain minimal or no free, pharmacologically active niacin and therefore lack beneficial lipid-modifying effects. To clarify important differences between available prescription and dietary supplement niacin products, this article contrasts current regulatory standards for dietary supplements and prescription drugs and provides an overview of available clinical data from key trials of niacin. PMID:21474895

Backes, James M; Padley, Robert J; Moriarty, Patrick M

2011-03-01

382

Hazard assessment of germanium supplements.  

PubMed

Germanium-containing dietary supplements became popular in the 1970s in Japan and later in other countries, as elixirs for certain diseases (e.g., cancer and AIDS). Germanium is not an essential element. Its acute toxicity is low. However, at least 31 reported human cases linked prolonged intake of germanium products with renal failure and even death. Signs of kidney dysfunction, kidney tubular degeneration, and germanium accumulation were observed. Other adverse effects were anemia, muscle weakness, and peripheral neuropathy. Recovery of renal function is slow and incomplete even long after germanium intake was stopped. The total dose of ingested germanium (as dioxide, carboxyethyl germanium sesquioxide, germanium-lactate-citrate, or unspecified forms) varied from 15 to over 300 g; the exposure duration varied from 2 to 36 months. In laboratory animals, elevated germanium in tissues and impaired kidney and liver function were observed in a life-time drinking water (5 ppm germanium) study. Other toxicities associated with ingested germanium products in human cases were also demonstrated in animal studies with germanium dioxide and sometimes other germanium compounds. Based on the evidence of persistent renal toxicity associated with germanium dioxide, the lack of conclusive findings of differential nephrotoxicity of organic germanium compounds, and the possibility of contamination of the organic germanium products with inorganic germanium, it is clear that germanium products present a potential human health hazard. PMID:9237323

Tao, S H; Bolger, P M

1997-06-01

383

Efficacy and Safety of Intravenous Iron Therapy for HCV-Positive Haemodialysis Patients  

Microsoft Academic Search

Background: Iron supplementation is the cornerstone of anaemia management in haemodialysis (HD) patients. However, efficacy and safety of intravenous (IV) iron therapy in hepatitis C virus (HCV)-positive HD patients is yet to be elucidated. Methods: Sixty-six maintenance HD patients with suboptimal response to recombinant human erythropoietin (rh-EPO) were administered IV iron. Each patient received 100 mg\\/session IV iron sucrose for

Serkan Kahraman; Rahmi Yilmaz; Gultekin Genctoy; Mustafa Arici; Bulent Altun; Yunus Erdem; Unal Yasavul; Cetin Turgan

2005-01-01

384

Preliminary Efficacy of a Cognitive-Behavioral Treatment Program for Anxious Youth with Autism Spectrum Disorders  

Microsoft Academic Search

Anxiety is a commonly occurring psychiatric concern in adolescents with autism spectrum disorders (ASD). This pilot study\\u000a examined the preliminary efficacy of a manual-based intervention targeting anxiety and social competence in four adolescents\\u000a with high-functioning ASD. Anxiety and social functioning were assessed at baseline, midpoint, endpoint, and 6 months following\\u000a treatment. Treatment consisted of cognitive-behavioral therapy, supplemented with parent education and

Susan W. White; Thomas Ollendick; Lawrence Scahill; Donald Oswald; Anne Marie Albano

2009-01-01

385

Technology Professional Development: Long-Term Effects on Teacher Self-Efficacy  

Microsoft Academic Search

The West Virginia K-12 RuralNet Project was an NSF funded program to train inservice teachers on integrating the Internet into science and mathematics curriculum. The program involved training inservice teachers through an intensive summer workshop and supplemental online courses. This study examines the effects of the project on the long-term self-efficacy of inservice teachers and their use of the Internet

George Watson

2006-01-01

386

Anemia among school children in Vietnam: the efficacy of iron fortification  

Microsoft Academic Search

The present thesis aimed to determine the efficacy of a school-based food fortification program to improve hemoglobin concentrations and iron stores of intestinal parasites-prone school children<\\/span>. Furthermore this thesis also compares the effect of iron fortification and iron supplementation on the changes in hemoglobin and iron status. <\\/o:p><\\/strong><\\/span><\\/span>A cross-sectional study among school children (6-8 years) in Tam Nong district

Le Thi Huong

2006-01-01

387

Effect of Preventive Supplementation with Zinc and Other Micronutrients on Non-Malarial Morbidity in Tanzanian Pre-School Children: A Randomized Trial  

PubMed Central

Background The efficacy of preventive zinc supplementation against diarrhea and respiratory illness may depend on simultaneous supplementation with other micronutrients. We aimed to assess the effect of supplementation with zinc and multiple micronutrients on diarrhea and other causes of non-malarial morbidity. Methods and Findings Rural Tanzanian children (n?=?612) aged 6–60 months and with height-for-age z-score < –1.5 SD were randomized to daily supplementation with zinc (10 mg) alone, multi-nutrients without zinc, multi-nutrients with zinc, or placebo. Children were followed for an average of 45 weeks. During follow-up, we recorded morbidity episodes. We found no evidence that concurrent supplementation with multi-nutrients influenced the magnitude of the effect of zinc on rates of diarrhea, respiratory illness, fever without localizing signs, or other illness (guardian-reported illness with symptoms involving skin, ears, eyes and abscesses, but excluding trauma or burns). Zinc supplementation reduced the hazard rate of diarrhea by 24% (4%–40%). By contrast, multi-nutrients seemed to increase this rate (HR; 95% CI: 1.19; 0.94–1.50), particularly in children with asymptomatic Giardia infection at baseline (2.03; 1.24–3.32). Zinc also protected against episodes of fever without localizing signs (0.75; 0.57–0.96), but we found no evidence that it reduced the overall number of clinic visits. Conclusions We found no evidence that the efficacy of zinc supplements in reducing diarrhea rates is enhanced by concurrent supplementation with other micronutrients. By reducing rates of fever without localizing signs, supplementation with zinc may reduce inappropriate drug use with anti-malarial medications and antibiotics. Trial Registration ClinicalTrials.gov NCT00623857

Veenemans, Jacobien; Schouten, Laura R. A.; Ottenhof, Maarten J.; Mank, Theo G.; Uges, Donald R. A.; Mbugi, Erasto V.; Demir, Ayse Y.; Kraaijenhagen, Rob J.; Savelkoul, Huub F. J.; Verhoef, Hans

2012-01-01

388

Interaction of Carbamazepine with Herbs, Dietary Supplements, and Food: A Systematic Review  

PubMed Central

Background. Carbamazepine (CBZ) is a first-line antiepileptic drug which may be prone to drug interactions. Systematic review of herb- and food-drug interactions on CBZ is warranted to provide guidance for medical professionals when prescribing CBZ. Method. A systematic review was conducted on six English databases and four Chinese databases. Results. 196 out of 3179 articles fulfilled inclusion criteria, of which 74 articles were reviewed and 33 herbal products/dietary supplement/food interacting with CBZ were identified. No fatal or severe interactions were documented. The majority of the interactions were pharmacokinetic-based (80%). Traditional Chinese medicine accounted for most of the interactions (n = 17), followed by food (n = 10), dietary supplements (n = 3), and other herbs/botanicals (n = 3). Coadministration of 11 and 12 of the studied herbal products/dietary supplement/food significantly decreased or increased the plasma concentrations of CBZ. Regarding pharmacodynamic interaction, Xiao-yao-san, melatonin, and alcohol increased the side effects of CBZ while caffeine lowered the antiepileptic efficacy of CBZ. Conclusion. This review provides a comprehensive summary of the documented interactions between CBZ and herbal products/food/dietary supplements which assists healthcare professionals to identify potential herb-drug and food-drug interactions, thereby preventing potential adverse events and improving patients' therapeutic outcomes when prescribing CBZ.

Zuo, Zhong

2013-01-01

389

Absorption and bioeffects of an isoflavone-based supplementation in postmenopausal women  

PubMed Central

Epidemiological studies suggest that consumption of isoflavones rich diets can improve several postmenopausal complications. The aim of this study was to investigate the absorption and the efficacy of isoflavonic supplementation in the treatment of menopausal symptoms. 36 postmenopausal women received 75 mg/day of isoflavones in the form of tablets, for six months. 21 subjects concluded the treatment. Plasmatic and urinary samples were collected before and after the treatment, along with a dietary interview. Isoflavones were determined in biological samples and in commercial administered supplements by a HPLC/DAD system. Results showed the presence of genistein (from 0.043 to 1.820 micromol/L) in plasma samples, and of genistein (from 2.486 to 20.363 micromol/24h) and daidzein (from 11.106 to 98.091 micromol/24h) in the urines of the treated women. In the 21 completers the Greene Climateric scale value for hot flushes changed from 3 to 1 or 0. No changes of the endometrial thickness and of the breast tissue were detected. The analysis of the supplement content in the tablets was in agreement with what declared by the producer. Administration of isoflavone supplements produced a decrease of symptoms in this cohort of postmenopausal women monitored for isoflavone absorption.

Pampaloni, Barbara; Bartolini, Silvia; Bartolini, Elisa; Ottanelli, Silva; Masi, Laura; Romani, Annalisa; Tanini, Annalisa; Vignolini, Pamela; Brandi, Maria Luisa

2009-01-01

390

Tauroursodeoxycholic acid (TUDCA) supplementation prevents cognitive impairment and amyloid deposition in APP/PS1 mice.  

PubMed

Alzheimer's disease (AD) is a neurodegenerative disease hallmarked by extracellular A?(1-42) containing plaques, and intracellular neurofibrillary tangles (NFT) containing hyperphosphorylated tau protein. Progressively, memory deficits and cognitive disabilities start to occur as these hallmarks affect hippocampus and frontal cortex, regions highly involved in memory. Connective tissue growth factor (CTGF) expression, which is high in the vicinity of A? plaques and NFTs, was found to influence ?-secretase activity, the molecular crux in A?(1-42) production. Tauroursodeoxycholic acid (TUDCA) is an endogenous bile acid that downregulates CTGF expression in hepatocytes and has been shown to possess therapeutic efficacy in neurodegenerative models. To investigate the possible in vivo therapeutic effects of TUDCA, we provided 0.4% TUDCA-supplemented food to APP/PS1 mice, a well-established AD mouse model. Six months of TUDCA supplementation prevented the spatial, recognition and contextual memory defects observed in APP/PS1 mice at 8 months of age. Furthermore, TUDCA-supplemented APP/PS1 mice displayed reduced hippocampal and prefrontal amyloid deposition. These effects of TUDCA supplementation suggest a novel mechanistic route for Alzheimer therapeutics. PMID:22974733

Lo, Adrian C; Callaerts-Vegh, Zsuzsanna; Nunes, Ana F; Rodrigues, Cecília M P; D'Hooge, Rudi

2012-09-10

391

Dietary supplement labeling and advertising claims: are clinical studies on the full product required?  

PubMed

Whether labeling and advertising claims for multi-ingredient dietary supplements may be based on the testing of individual, key ingredients--rather than the actual product--has caused a good deal of confusion. This confusion stems from the dearth of case law and the open-endedness of Federal Trade Commission (FTC) and Food and Drug Administration (FDA) guidance on this issue. Nevertheless, the relevant regulatory guidance, case law and self-regulatory case law--when assessed together--indicate that the law allows and even protects "key ingredient claims" (i.e., claims based on efficacy testing of key ingredients in the absence of full product testing). This article provides an overview of the relevant substantiation requirements for dietary supplement claims and then reviews FTC's and FDA's guidance on key ingredient claims; relevant case law; use of key ingredient claims in the advertising of other consumer products; and the National Advertising Division of the Better Business Bureau, Inc.'s (NAD's) approach to evaluating key ingredient claims for dietary supplements. This article concludes that key ingredient claims--provided they are presented in a truthful and non-deceptive manner--are permissible, and should be upheld in litigation and cases subject to industry self-regulation. This article further concludes that the NAD's approach to key ingredient claims provides practical guidance for crafting and substantiating dietary supplement key ingredient claims. PMID:19998572

Villafranco, John E; Bond, Katie

2009-01-01

392

Impact of zinc supplementation in malnourished children with acute watery diarrhoea.  

PubMed

A double-blind, randomized, controlled clinical trial was conducted on 80 malnourished children with acute dehydrating diarrhoea to evaluate the efficacy of oral supplementation of zinc as an adjunct therapy to oral rehydration solution (ORS). After decoding it was observed that 44 children received zinc sulphate (177 mg/kg/day in three divided doses equivalent to 40 mg elemental zinc) in a syrup form and 36 children received only syrup placebo. Clinical parameters and microbiological findings of stool samples were comparable in the two groups at the time of enrollment. All the children (100 per cent) in the zinc supplemented group and 32 (89 per cent) children in the placebo group recovered within 5 days of hospitalization (p = 0.04). The zinc supplemented group had a significantly shorter duration of diarrhoea (70.4 +/- 10.0 vs. 103.4 +/- 17.1 h; p = 0.0001), passed less liquid stool (1.5 +/- 0.7 vs. 2.4 +/- 0.7kg; p=0.0001), consumed less oral rehydration solution (2.5 +/- 1.0 vs. 3.6 +/- 0.8 litre; p = 0.0001) and other liquids (867.0 +/- 466.1 vs. 1354.7 +/- 675.6 ml; p = 0.0001) as compared to the placebo group. Our findings suggest that zinc supplementation as an adjunct therapy to ORS has beneficial effects on the clinical course of dehydrating acute diarrhoea. PMID:11077932

Dutta, P; Mitra, U; Datta, A; Niyogi, S K; Dutta, S; Manna, B; Basak, M; Mahapatra, T S; Bhattacharya, S K

2000-10-01

393

40 CFR 192.22 - Supplemental standards.  

Code of Federal Regulations, 2013 CFR

...PROTECTION AGENCY (CONTINUED) RADIATION PROTECTION PROGRAMS HEALTH AND ENVIRONMENTAL PROTECTION STANDARDS FOR URANIUM AND THORIUM MILL TAILINGS Implementation § 192.22 Supplemental standards. Federal agencies implementing subparts A and...

2013-07-01

394

Sanitary Landfill Supplemental Test Final Report  

SciTech Connect

This report summarizes the performance of the Sanitary Landfill Supplemental Test data, an evaluation of applicability, conclusions, recommendations, and related information for implementation of this remediation technology at the SRS Sanitary Landfill.

Altman, D.J.

1999-07-28

395

Guidance for Industry: Substantiation for Dietary Supplement ...  

Center for Food Safety and Applied Nutrition (CFSAN)

... If you want to discuss an alternative approach, contact ... conditions seen only in the elderly, the study ... 7: A dietary supplement firm wants to promote ... More results from www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation

396

15 CFR 908.7 - Supplemental reports.  

Code of Federal Regulations, 2013 CFR

...REGULATIONS MAINTAINING REC-ORDS AND SUBMITTING REPORTS ON WEATHER MODIFICATION ACTIVITIES § 908.7 Supplemental reports...must be made to the Administrator immediately if any report of weather modification activities submitted under § 908.4, §...

2013-01-01

397

47 CFR 87.527 - Supplemental eligibility.  

Code of Federal Regulations, 2011 CFR

...Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES Automatic Weather Stations (AWOS/ASOS) § 87.527 Supplemental eligibility. (a) Licenses will be granted only upon FAA...

2011-10-01

398

47 CFR 87.527 - Supplemental eligibility.  

Code of Federal Regulations, 2012 CFR

...Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES Automatic Weather Stations (AWOS/ASOS) § 87.527 Supplemental eligibility. (a) Licenses will be granted only upon FAA...

2012-10-01

399

7 CFR 2201.29 - Supplemental guarantees.  

Code of Federal Regulations, 2013 CFR

...Section 2201.29 Agriculture Regulations of the Department of Agriculture (Continued) LOCAL TELEVISION LOAN GUARANTEE BOARD LOCAL TELEVISION LOAN GUARANTEE PROGRAM-PROGRAM REGULATIONS Loan Guarantees § 2201.29 Supplemental...

2013-01-01

400

13 CFR 400.215 - Supplemental Guarantees.  

Code of Federal Regulations, 2013 CFR

...Guarantees. 400.215 Section 400.215 Business Credit and Assistance EMERGENCY STEEL GUARANTEE LOAN BOARD EMERGENCY STEEL GUARANTEE LOAN PROGRAM Steel Guarantee Loans § 400.215 Supplemental Guarantees. The Board will...

2013-01-01

401

13 CFR 400.215 - Supplemental Guarantees.  

Code of Federal Regulations, 2012 CFR

...Guarantees. 400.215 Section 400.215 Business Credit and Assistance EMERGENCY STEEL GUARANTEE LOAN BOARD EMERGENCY STEEL GUARANTEE LOAN PROGRAM Steel Guarantee Loans § 400.215 Supplemental Guarantees. The Board will...

2012-01-01

402

47 CFR 87.419 - Supplemental eligibility.  

Code of Federal Regulations, 2012 CFR

...SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES Airport Control Tower Stations § 87.419 Supplemental eligibility... Only one control tower or RCO will be licensed at an airport. [64 FR 27476, May 20,...

2012-10-01

403

47 CFR 87.419 - Supplemental eligibility.  

Code of Federal Regulations, 2011 CFR

...SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES Airport Control Tower Stations § 87.419 Supplemental eligibility... Only one control tower or RCO will be licensed at an airport. [64 FR 27476, May 20,...

2011-10-01

404

Do fat supplements increase physical performance?  

PubMed

Fish oil and conjugated linoleic acid (CLA) belong to a popular class of food supplements known as "fat supplements", which are claimed to reduce muscle glycogen breakdown, reduce body mass, as well as reduce muscle damage and inflammatory responses. Sport athletes consume fish oil and CLA mainly to increase lean body mass and reduce body fat. Recent evidence indicates that this kind of supplementation may have other side-effects and a new role has been identified in steroidogenensis. Preliminary findings demonstrate that fish oil and CLA may induce a physiological increase in testosterone synthesis. The aim of this review is to describe the effects of fish oil and CLA on physical performance (endurance and resistance exercise), and highlight the new results on the effects on testosterone biosynthesis. In view of these new data, we can hypothesize that fat supplements may improve the anabolic effect of exercise. PMID:23434906

Macaluso, Filippo; Barone, Rosario; Catanese, Patrizia; Carini, Francesco; Rizzuto, Luigi; Farina, Felicia; Di Felice, Valentina

2013-02-07

405

47 CFR 87.239 - Supplemental eligibility.  

Code of Federal Regulations, 2011 CFR

...Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES Aeronautical Multicom Stations § 87.239 Supplemental eligibility. Each applicant for a multicom may be required to...

2011-10-01

406

47 CFR 87.239 - Supplemental eligibility.  

Code of Federal Regulations, 2012 CFR

...Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES Aeronautical Multicom Stations § 87.239 Supplemental eligibility. Each applicant for a multicom may be required to...

2012-10-01

407

Vitamin B Supplements May Guard Against Stroke  

MedlinePLUS

... enable JavaScript. Vitamin B Supplements May Guard Against Stroke Review found they reduced risk by 7 percent, ... September 18, 2013 Related MedlinePlus Pages B Vitamins Stroke WEDNESDAY, Sept. 18 (HealthDay News) -- Taking vitamin B ...

408

Dietary Supplement Labeling Guide: Chapter VIII. Other ...  

Center for Food Safety and Applied Nutrition (CFSAN)

... You must label any dietary supplement in solid oral ... must also place it on any labeling that contains ... a claim indicating that my product is organic? ... More results from www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation

409

Dietary Supplements Reporting an Adverse Event  

Center for Food Safety and Applied Nutrition (CFSAN)

Text Version... The manufacturer, packer, or distributor of a dietary supplement marketed in the United States whose name appears on the label of the supple ... More results from www.fda.gov/downloads/food/dietarysupplements

410

New Dietary Ingredients in Dietary Supplements - Background ...  

Center for Food Safety and Applied Nutrition (CFSAN)

... New Dietary Ingredients in Dietary Supplements - Background for Industry. ... When to Notify FDA and What is a New Dietary Ingredient. ... More results from www.fda.gov/food/dietarysupplements/newdietaryingredientsnotificationprocess

411

Do Fat Supplements Increase Physical Performance?  

PubMed Central

Fish oil and conjugated linoleic acid (CLA) belong to a popular class of food supplements known as “fat supplements”, which are claimed to reduce muscle glycogen breakdown, reduce body mass, as well as reduce muscle damage and inflammatory responses. Sport athletes consume fish oil and CLA mainly to increase lean body mass and reduce body fat. Recent evidence indicates that this kind of supplementation may have other side-effects and a new role has been identified in steroidogenensis. Preliminary findings demonstrate that fish oil and CLA may induce a physiological increase in testosterone synthesis. The aim of this review is to describe the effects of fish oil and CLA on physical performance (endurance and resistance exercise), and highlight the new results on the effects on testosterone biosynthesis. In view of these new data, we can hypothesize that fat supplements may improve the anabolic effect of exercise.

Macaluso, Filippo; Barone, Rosario; Catanese, Patrizia; Carini, Francesco; Rizzuto, Luigi; Farina, Felicia; Felice, Valentina Di

2013-01-01

412

Tips for Older Dietary Supplement Users  

MedlinePLUS

... sure that you are getting all the vitamins, minerals, and other nutrients you need as you get ... Today's dietary supplements are not only vitamins and minerals. They also include other less-familiar substances, such ...

413

Dietary Supplement Current Good Manufacturing Practices ...  

Center for Food Safety and Applied Nutrition (CFSAN)

... To limit any disruption for dietary supplements produced by small businesses, the rule has a staggered three-year phase-in for small businesses. ... More results from www.fda.gov/food/guidanceregulation/cgmp

414

Nutritional supplementation: is it necessary for everybody?  

PubMed

Mineral nutrients, vitamins, and trace elements are essential for the growth and development of a multicellular organism. Today, an adequate supply of nutrients is often unattainable solely through a well-balanced diet, so a targeted, individually designed dietary supplement regime is necessary. Nutrient deficiency, which is impossible to detect through plasma levels alone, is reliably detected through the intracellular measurement of the nutrient levels in the blood. Two case studies presented here indicate the need for supplementation as improvement in nutritional behavior could not replenish already exhausted nutrient reservoirs. Only supplementation was able to significantly boost nutrient levels and confer beneficial effects on general welfare, physical performance, and resistance to infections. Therefore, it appears that nutritional supplements are advisable for everyone, but more research is needed, especially on an intracellular level, to corroborate these findings. PMID:18029339

Wienecke, Elmar; Gruenwald, Joerg

415

Withdrawal of "Guidance for Industry: Supplemental Testing ...  

Center for Biologics Evaluation and Research (CBER)

... for hepatitis C and supplemental testing, and the ... and blood recipients of donor test results for ... 1998) concerning results of donations tested prior to ... More results from www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances

416

Obesity and hormonal contraceptive efficacy.  

PubMed

Obesity is a major public health concern affecting an increasing proportion of reproductive-aged women. Avoiding unintended pregnancy is of major importance, given the increased risks associated with pregnancy, but obesity may affect the efficacy of hormonal contraceptives by altering how these drugs are absorbed, distributed, metabolized or eliminated. Limited data suggest that long-acting, reversible contraceptives maintain excellent efficacy in obese women. Some studies demonstrating altered pharmacokinetic parameters and increased failure rates with combined oral contraceptives, the contraceptive patch and emergency contraceptive pills suggest decreased efficacy of these methods. It is unclear whether bariatric surgery affects hormonal contraceptive efficacy. Obese women should be offered the full range of contraceptive options, with counseling that balances the risks and benefits of each method, including the risk of unintended pregnancy. PMID:24007251

Robinson, Jennifer A; Burke, Anne E

2013-09-01

417

Creatine Supplementation in Strength-Power Sports  

Microsoft Academic Search

The exogenous ingestion of creatine (Cr) is typically used as a performance enhancing (ergogenic) supplement because it is\\u000a known to improve performance in muscular strength and power activities, enhance short bursts of muscular endurance, and allow\\u000a for greater muscular overload in order to improve training effectiveness. Creatine has become one of the most popular ingested\\u000a nutritional supplements due to its

Darryn S. Willoughby

418

Studies on the safety of creatine supplementation  

Microsoft Academic Search

Doubtful allegations of adverse effects of creatine supplementation have been released through the press media and through\\u000a scientific publications. In the present review we have tried to separate the wheat from the chaff by looking for the experimental\\u000a evidence of any such claims. Anecdotal reports from athletes have appeared on muscle cramp and gastrointestinal complaints\\u000a during creatine supplementation, but the

Hyo Jeong Kim; Chang Keun Kim; A. Carpentier; Jacques R. Poortmans

2011-01-01

419

Supplemental feeding program for California condors  

USGS Publications Warehouse

A 2-year supplemental feeding program for the endangered California condor (Gymnogyps californianus) was of insufficient length to definitely show that a dependable food supply will stimulate additional breeding; however, production did increase during the study, and food supply appears a likely cause. Because no undesirable effects of feeding were noted, and because condor production is now critically low, an expanded supplemental feeding program is recommended.

Wilbur, S.R.; Carrier, W.D.; Borneman, J.C.

1974-01-01

420

Micronutrient supplementation and the intelligence of children  

Microsoft Academic Search

A growing number of double-blind placebo-controlled studies have considered the influence of micro-nutrient supplementation on the intelligence of children. Earlier studies prevented the drawing of conclusions as they did not systematically approach the topic. However, over the last 10 years, a series of studies have compared the impact of supplementation on either verbal or non-verbal measures of intelligence. In 10

D. Benton

2001-01-01

421

Articaine for Supplemental Buccal Mandibular Infiltration Anesthesia in Patients with Irreversible Pulpitis When the Inferior Alveolar Nerve Block Fails  

Microsoft Academic Search

The purpose of this prospective study was to determine the anesthetic efficacy of the supplemental buccal infiltration injection of a cartridge of 4% articaine with 1:100,000 epinephrine in mandibular posterior teeth diagnosed with irreversible pulpitis when the conventional inferior alveolar nerve (IAN) block failed. Fifty-five emergency patients, diagnosed with irreversible pulpitis of a mandibular posterior tooth, received an IAN block

Rachel Matthews; Melissa Drum; Al Reader; John Nusstein; Mike Beck

2009-01-01

422

A pilot randomized controlled trial of oral calcium and vitamin D supplementation using fortified laddoos in underprivileged Indian toddlers  

Microsoft Academic Search

Background\\/Objectives:Low habitual dietary calcium intake and vitamin D deficiency are common among Indian children. Using ‘laddoo’, an Indian snack, as a vehicle for administering calcium and vitamin D supplements, a randomized double-blind controlled trial was conducted for 12 months to assess its efficacy on total body less head (TBLH) bone mineral content (BMC) in underprivileged toddlers.Subjects\\/Methods:A total of 60 toddlers

V H Ekbote; A V Khadilkar; S A Chiplonkar; N M Hanumante; V V Khadilkar; M Z Mughal

2011-01-01

423

Effects of calcium supplements on femoral bone mineral density and vertebral fracture rate in vitamin-D-replete elderly patients  

Microsoft Academic Search

The efficacy of calcium (Ca) in reducing bone loss is debated. In a randomized placebo-controlled double-masked study, we investigated the effects of oral Ca supplements on femoral shaft (FS), femoral neck (FN) and lumbar spine (LS) bone mineral density (BMD), and on the incidence of vertebral fracture in vitamin-D-replete elderly. Ninety-three healthy subjects (72.1±0.6 years) were randomly allocated to three

T. Chevalley; R. Rizzoli; V. Nydegger; D. Slosman; C.-H. Rapin; J.-P. Michel; H. Vasey; J.-P. Bonjour

1994-01-01

424

Zinc or Multiple Micronutrient Supplementation to Reduce Diarrhea and Respiratory Disease in South African Children: A Randomized Controlled Trial  

Microsoft Academic Search

BackgroundProphylactic zinc supplementation has been shown to reduce diarrhea and respiratory illness in children in many developing countries, but its efficacy in children in Africa is uncertain.ObjectiveTo determine if zinc, or zinc plus multiple micronutrients, reduces diarrhea and respiratory disease prevalence.DesignRandomized, double-blind, controlled trial.SettingRural community in South Africa.ParticipantsThree cohorts: 32 HIV-infected children; 154 HIV-uninfected children born to HIV-infected mothers; and

Kany-Kany Angelique Luabeya; Nontobeko Mpontshane; Malanie Mackay; Honorine Ward; Inga Elson; Meera Chhagan; Andrew Tomkins; Jan Van Den Broeck; Michael L. Bennish; Jose M. Belizan

2007-01-01

425

The effects of short-term alpha-ketoisocaproic acid supplementation on exercise performance: a randomized controlled trial  

Microsoft Academic Search

BACKGROUND: This study examined the efficacy of short-term alpha-ketoisocaproic acid (KIC) monotherapy supplementation immediately prior to moderate- and high-intensity single bout exercise performance. METHODS: Thirteen resistance trained men (22.8 ± 2.5 years; 81.6 ± 12.6 kg) participated in a prospective, randomized, double blind, placebo controlled crossover experiment. Each subject completed one familiarization and four experimental trials with either 1.5 g

Joshua F Yarrow; Jeffrey J Parr; Lesley J White; Paul A Borsa; Bruce R Stevens

2007-01-01

426

Effects of low-dose caffeine supplementation on early morning performance in the standing shot put throw  

Microsoft Academic Search

The purpose of the present investigation was to assess the efficacy of low-dose caffeine use for early morning performance in the shot put event. A double-blind, randomized, crossover design was used to investigate the effects of buccal caffeine supplementation on early morning shot put execution in nine inter-collegiate track and field athletes. In one condition the participants received a piece

David M. Bellar; Gary Kamimori; Lawrence Judge; Jacob E. Barkley; Edward J. Ryan; Matthew Muller; Ellen L. Glickman

2012-01-01

427

Effects of low-dose caffeine supplementation on early morning performance in the standing shot put throw  

Microsoft Academic Search

The purpose of the present investigation was to assess the efficacy of low-dose caffeine use for early morning performance in the shot put event. A double-blind, randomized, crossover design was used to investigate the effects of buccal caffeine supplementation on early morning shot put execution in nine inter-collegiate track and field athletes. In one condition the participants received a piece

David M. Bellar; Gary Kamimori; Lawrence Judge; Jacob E. Barkley; Edward J. Ryan; Matthew Muller; Ellen L. Glickman

2011-01-01

428

Effects of Microbial Phytase Supplementation and Soaking of Barley-Soybean Meal on Availability of Plant Phosphorus for Growing Pigs  

Microsoft Academic Search

The efficacy of phytase supplement, 1200 U\\/kg, produced by Aspergillus niger on phytin phosphorus (P) availability was assayed in a 6 × 6 Latin square designed digestibility and balance trial with growing pigs at live weight 35–88 kg. The pigs were fed on barley-soybean meal diets without inorganic P either soaked for 3 h or without soaking. The P content

Matti Näsi; Eija Helander

1994-01-01

429

Prospective study of the modified atkins diet in combination with a ketogenic liquid supplement during the initial month.  

PubMed

The modified Atkins diet is a high-fat, low-carbohydrate treatment for intractable childhood epilepsy. As data suggest that a stricter diet onset can be more effective, we added a ketogenic supplement to the modified Atkins diet during its initial month. Thirty children with intractable epilepsy were prospectively started on the modified Atkins diet in combination with a daily 400-calorie KetoCal shake. At 1 month, 24 (80%) children had >50% seizure reduction, of which 11 (37%) had >90% seizure reduction. There was no significant loss of efficacy during the second month after KetoCal was discontinued. The use of this ketogenic supplement increased daily fat intake and thus the ketogenic ratio (1.8:1 versus 1.0:1 in the modified Atkins diet alone, P = .0002), but did not change urinary or serum ketosis. The addition of a ketogenic supplement to the modified Atkins diet during its initial month appears to be beneficial. PMID:20833798

Kossoff, Eric H; Dorward, Jennifer L; Turner, Zahava; Pyzik, Paula L

2010-09-10

430

 Hepatotoxicity associated with dietary energy supplements: use and abuse by young athletes.  

PubMed

 In recent years there has been a significant increase in the consumption of dietary energy supplements (DES) associated with the parallel advertising against obesity and favoring high physical performance. We present the case and outcome of a young patient who developed acute mixed liver injury (hepatocellular and cholestatic) after ingestion of various "over the counter" products to increase muscle mass and physical performance (NO Xplode®, creatine, L-carnitine, and Growth Factor ATN®). The diagnosis was based on the exclusion of other diseases and liver biopsy findings. The dietary supplement and herbal multivitamins industry is one with the highest growth rates in the market, with annual revenues amounting to billions and constantly lacking scientific or reproducible evidence about the efficacy and/or safety of the offered products. Furthermore, and contrary to popular belief, different forms of injury associated with these natural substances have been documented particularly in the liver, supporting the need of a more strict regulation. PMID:22700641

Avelar-Escobar, Giovanni; Méndez-Navarro, Jorge; Ortiz-Olvera, Nayeli X; Castellanos, Guillermo; Ramos, Roberto; Gallardo-Cabrera, Víctor E; Vargas-Alemán, José de Jesús; Díaz de León, Oscar; Rodríguez, Elda V; Dehesa-Violante, Margarita

431

Dietary Fiber Supplements: Effects in Obesity and Metabolic Syndrome and Relationship to Gastrointestinal Functions  

PubMed Central

Dietary fiber (DF) is a term that reflects to a heterogenous group of natural food sources, processed grains and commercial supplements. Several forms of DF have been used as complementary or alternative agents in the management of manifestations of the metabolic syndrome, including obesity. Not surprisingly, there is a great variation in the biological efficacy of DF in metabolic syndrome and body weight control. Diverse factors and mechanisms have been reported as mediators of the effects of DF on the metabolic syndrome and obesity. Among this array of mechanisms, the modulation of gastric sensorimotor influences appears to be crucial for the effects of DF, but also quite variable. This article focuses on the role, mechanism of action and benefits of different forms of fiber and supplements on obesity and metabolic syndrome, glycemia, dyslipidemia, cardiovascular risk, and explores the effects of DF on gastric sensorimotor function and satiety in mediating these actions of DF.

Papathanasopoulos, Athanasios; Camilleri, Michael

2010-01-01

432

Maternal multiple micronutrient supplementation and pregnancy outcomes in developing countries: meta-analysis and meta-regression  

PubMed Central

Abstract Objective To systematically review randomized controlled trials comparing the effect of supplementation with multiple micronutrients versus iron and folic acid on pregnancy outcomes in developing countries. Methods MEDLINE and EMBASE were searched. Outcomes of interest were birth weight, low birth weight, small size for gestational age, perinatal mortality and neonatal mortality. Pooled relative risks (RRs) were estimated by random effects models. Sources of heterogeneity were explored through subgroup meta-analyses and meta-regression. Findings Multiple micronutrient supplementation was more effective than iron and folic acid supplementation at reducing the risk of low birth weight (RR:?0.86, 95% confidence interval, CI:?0.79–0.93) and of small size for gestational age (RR:?0.85; 95% CI: 0.78–0.93). Micronutrient supplementation had no overall effect on perinatal mortality (RR:?1.05; 95% CI:?0.90–1.22), although substantial heterogeneity was evident (I2?=?58%; P for heterogeneity?=?0.008). Subgroup and meta-regression analyses suggested that micronutrient supplementation was associated with a lower risk of perinatal mortality in trials in which >?50% of mothers had formal education (RR:?0.93; 95% CI:?0.82–1.06) or in which supplementation was initiated after a mean of 20 weeks of gestation (RR:?0.88; 95% CI:?0.80–0.97). Conclusion Maternal education or gestational age at initiation of supplementation may have contributed to the observed heterogeneous effects on perinatal mortality. The safety, efficacy and effective delivery of maternal micronutrient supplementation require further research.

Spiegelman, Donna; Shankar, Anuraj H; Fawzi, Wafaie W

2011-01-01

433

The use of dietary supplements by athletes.  

PubMed

Many athletes use dietary supplements as part of their regular training or competition routine, including about 85% of elite track and field athletes. Supplements commonly used include vitamins, minerals, protein, creatine, and various "ergogenic" compounds. These supplements are often used without a full understanding or evaluation of the potential benefits and risks associated with their use, and without consultation with a sports nutrition professional. A few supplements may be helpful to athletes in specific circumstances, especially where food intake or food choice is restricted. Vitamin and mineral supplements should be used only when a food-based solution is not available. Sports drinks, energy bars, and protein-carbohydrate shakes may all be useful and convenient at specific times. There are well-documented roles for creatine, caffeine, and alkalinizing agents in enhancing performance in high-intensity exercise, although much of the evidence does not relate to specific athletic events. There are potential costs associated with all dietary supplements, including the risk of a positive doping result as a consequence of the presence of prohibited substances that are not declared on the label. PMID:18049988

Maughan, Ronald J; Depiesse, Frederic; Geyer, Hans

2007-01-01

434

Consumers’ Knowledge and Use of Vitamin and Mineral Supplements  

Microsoft Academic Search

Dietary supplement use is prevalent in the United States. Estimates suggest that 23–69% of the population consumes vitamin or mineral supplements. Health educators lack information needed to develop appropriate educational programs regarding supplements for consumers. This research was designed to investigate the relationship between knowledge and vitamin and mineral supplement use. Adult consumers were surveyed via a mail questionnaire. Subjects

J. Horwitz Nehila

1999-01-01

435

Guide to over-the-counter sports supplements for athletes  

Microsoft Academic Search

Dietary supplements are used by at least 40% of athletes, and depending on the sport, up to 100%. Often multiple supplements are taken in higher than normal doses. Both competitive and recreational athletes take supplements, though sometimes for different reasons. Some take them to support a poor quality diet; others take supplements because they simply feel that an ordinary diet,

Norbert Baume; Ien Hellemans; Martial Saugy

2007-01-01

436

Contamination of dietary supplements and positive drug tests in sport  

Microsoft Academic Search

The use of dietary supplements is widespread in sport and most athletes competing at the highest level of competition use some form of dietary supplementation. Many of these supplements confer no performance or health benefit, and some may actually be detrimental to both performance and health when taken in high doses for prolonged periods. Some supplements contain excessive doses of

RJ Maughan

2005-01-01

437

WITHDRAWN: Glyconutrient Supplementation in Patients with Myasthenia Gravis.  

PubMed

Abstract Background: Numerous anecdotal reports claim that patients with myasthenia gravis (MG) may benefit from glyconutrient (GN) supplementation; however, little if any empirical evidence exists. This pilot study examined the benefits of GN supplementation on various objective and subjective physiologic measures related to MG. Methods: Seven (7) male and 12 female volunteer patients (n = 19) with symptomatic MG, ages 16-84 (54.79 +/- 18.36) were randomly assigned to either a GN intervention group (IG) or control-crossover group (CCG) that began the GN dietary intervention at 6 weeks. Patients were assessed at various time intervals over 52 weeks and included physiologic measures using the Quantitative Myasthenia Gravis Score (QMG) along with several self-report measures related to current health status. Results: At baseline, no significant differences (p > 0.05) existed between the CCG and IG on any of the test parameters. At 6 weeks, the IG demonstrated significantly (p < 0.01) improved QMG scores while the CCG remained essentially the same. The CCG, which had begun the dietary intervention protocol 6 weeks into the study, also exhibited significant (p < 0.01) improvement in QMG scores similar to that of the IG. At 52 weeks, the entire sample exhibited significant improvement (p < 0.01) in QMG scores from baseline. Significant (p < 0.05) percentage improvement was also reported from subjective measures of activities of daily living (78.3%), energy (81.0%), endurance (79.6%), productivity (92.8%), and quality of life (88.6%). Conclusions: Dietary support with GN may potentially provide physiologic benefits to patients with MG. Continued efficacy studies employing randomized placebo-controlled trials examining specific GN are warranted to evaluate possible autoimmune benefit. PMID:18973430

Randell, David J; Byars, Allyn; Williams, Freddie; Miller, Lajuana

2008-10-30

438

Recovery of sublethally heat-injured Salmonella typhimurium on supplemented plating media.  

PubMed Central

The efficacy of 32 additives to Levine eosin-methylene blue-salts agar medium (EMBS) for the recovery of sublethally heat-injured Salmonella typhimurium was evaluated. In order of decreasing effectiveness, lactate, mannitol, and alpha-glycerophosphate mediated 90% or more recovery of injured cells; similar levels of recovery were obtained on EMBS supplemented with 1% (wt/vol) tryptic soy broth, protease peptone, or plate count agar. Other additives showed little or no capacity for repair or strongly inhibited heated and nonheated cell suspensions. Conditions of growth and storage before heat treatment were also found to markedly affect susceptibility to heat injury.

D'Aoust, J Y

1978-01-01

439

Botanical and Dietary Supplements for Menopausal Symptoms: What Works, What Doesn't  

PubMed Central

All women reach menopause and approximately two-thirds of women develop menopausal symptoms, primarily hot flashes. Hormone therapy long was considered the first line of treatment for vasomotor symptoms. However, given the results of the Women’s Health Initiative, many women are reluctant use exogenous hormones for symptomatic treatment and are turning to botanicals and dietary supplement (BDS) products for relief. Despite the fact that there is limited scientific evidence describing efficacy and long term safety of such products, many women find these “natural treatments” appealing. Peri- and postmenopausal women are amongst the highest users of these products, but 70% of women do not tell their health care providers about their use. Compounding this issue is the fact that few clinicians ask their patients about use of BDS, largely because they have not been exposed to alternative medical practices in their training and are unfamiliar with these products. This paper reviews the botanicals and dietary supplements commonly used in menopause, (such as black cohosh, red clover, soy products, among others) as well as the available data on efficacy and safety. We searched the MEDLINE database from 1966 to December 2004 using terms related to botanical and dietary supplements and menopausal symptoms for peri- or postmenopausal women. Abstracts from relevant meetings as well as reference books and websites on herbal supplements were also searched. Randomized-controlled trials (RCTs) were used if available; open trials and comparison group studies were used when RCTs were not available. The evidence to date suggests that black cohosh is safe and effective for reducing menopausal symptoms, primarily hot flashes and possibly mood disorders. Phytoestrogen extracts, including soy foods and red clover appear to have at best only minimal effect on menopausal symptoms but have positive health effects on plasma lipid concentrations and may reduce heart disease. St. John’s wort has been shown to improve mild to moderate depression in the general population and appears to show efficacy for mood disorders related to the menopausal transition. Other commonly used botanicals have limited evidence to demonstrate safety and efficacy for relief of symptoms related to menopause.

Geller, Stacie E.; Studee, Laura

2006-01-01

440

Progress in developing analytical and label-based dietary supplement databases at the NIH Office of Dietary Supplements  

Microsoft Academic Search

Although an estimated 50% of adults in the United States consume dietary supplements, analytically substantiated data on their bioactive constituents are sparse. Several programs funded by the Office of Dietary Supplements (ODS) at the National Institutes of Health enhance dietary supplement database development and help to better describe the quantitative and qualitative contributions of dietary supplements to total dietary intakes.

Johanna T. Dwyer; Mary Frances Picciano; Joseph M. Betz; Kenneth D. Fisher; Leila G. Saldanha; Elizabeth A. Yetley; Paul M. Coates; John A. Milner; Jackie Whitted; Vicki Burt; Kathy Radimer; Jaimie Wilger; Katherine E. Sharpless; Joanne M. Holden; Karen Andrews; Janet Roseland; Cuiwei Zhao; Amy Schweitzer; James Harnly; Wayne R. Wolf; Charles R. Perry

2008-01-01

441

Dietary Supplement Ingredient Database (DSID): Preliminary USDA studies on composition of adult multivitamin/mineral supplements  

Technology Transfer Automated Retrieval System (TEKTRAN)

The Nutrient Data Laboratory, USDA, is collaborating with the Office of Dietary Supplements (ODS), the National Center for Health Statistics, and other government agencies to design and populate a Dietary Supplement Ingredient Database (DSID). This analytically based, publicly available database wi...

442

Supplemental photosynthetic lighting for greenhouse tomato production  

SciTech Connect

The influence of supplemental light on the growth and productivity of greenhouse tomatoes grown to a single cluster on movable benches is examined, and the economic feasibility of such a system is evaluated. Experiments were conducted to quantify the tomato plants' response to various levels of supplemental light in terms of growth rate and yield at various stages in their development (e.g., seedling, flowering plant, etc.). The 1984--85 experiments showed that supplemental photosynthetic lighting nearly doubled tomato yields, from 0.48 to 0.86 lbs/plant. Subsequent experiments in 1985--86 identified the best tomato varieties for this treatment and further increased yields to 1.3 lbs/plant. In addition, the use of supplemental lighting was found to hasten tomato crop maturity. An economic analysis was performed on the 1985--86 empirical data using the tax rates and provisions then in force. It indicated that a 10-acre greenhouse could provide an after-tax internal rate of return of 10% to 12% using only equity financing. This return could likely be increased to 15--18% with the use of combined debt/equity financing. Using supplemental lighting on 10,000 acres of greenhouse production would require an estimated 7.5 billion kWh of additional electricity per year and, at 4.7 cents/kWh, generate an estimated $350 million in additional utility revenues. 48 refs., 34 figs., 24 tabs.

Godfriaux, B.L.; Wittman, W.K. (Public Service Electric and Gas Co., Newark, NJ (USA)); Janes, H.W.; McAvoy, R.J.; Putman, J.; Logendra, S. (Rutgers--the State Univ., New Brunswick, NJ (USA). Dept. of Horticulture and Forestry); Mears, D.R.; Giacommelli, G.; Giniger, M. (Rutgers--the State Univ., New Brunswick, NJ (USA). Dept. of Biological and Agricultural Engineering)

1989-12-01

443

Chromium supplements: differences in utilization by humans  

SciTech Connect

Chromium (Cr) in the +3 oxidation state has been widely administered to subjects to examine the effects of Cr supplementation. The objective of the current project was to compare the differences in utilization of 2 Cr supplements in adult Midwestern women. Each woman serving as her own control randomly received the basal diet alone, basal diet + brewer's yeast and basal diet + chelated Cr containing 42 ..mu..g, 242 ..mu..g and 242 ..mu..g Cr daily, respectively. Treated urine and blood serum samples were analyzed in duplicate for Cr content using a Varian Techtron Atomic Absorption Spectrophotometer model 1275 equipped with a graphite furnace attachment. Mean urinary Cr excretion was similar for subjects consuming the basal diet alone or with the brewer's yeast supplement (0.16 ..mu..g/day). Use of chelated Cr supplementation led to significantly higher urinary Cr excretion (0.317 ..mu..g/day, P<0.03). This suggests that Cr supplied by chelated Cr was better than that supplied by yeast, although both supplements were apparently poorly absorbed in comparison to the Cr supplied by the diet. Blood serum Cr concentrations were not significantly altered by the experimental treatments.

Bizem, H.R.; Kies, C.; Fox, H.M.

1986-03-01

444

Nutrigenomic Analysis of Diet-Gene Interactions on Functional Supplements for Weight Management  

PubMed Central

Recent advances in molecular biology combined with the wealth of information generated by the Human Genome Project have fostered the emergence of nutrigenomics, a new discipline in the field of nutritional research. Nutrigenomics may provide the strategies for the development of safe and effective dietary interventions against the obesity epidemic. According to the World Health Organization, more than 60% of the global disease burden will be attributed to chronic disorders associated with obesity by 2020. Meanwhile in the US, the prevalence of obesity has doubled in adults and tripled in children during the past three decades. In this regard, a number of natural dietary supplements and micronutrients have been studied for their potential in weight management. Among these supplements, (–)-hydroxycitric acid (HCA), a natural extract isolated from the dried fruit rind of Garcinia cambogia, and the micronutrient niacin-bound chromium(III) (NBC) have been shown to be safe and efficacious for weight loss. Utilizing cDNA microarrays, we demonstrated for the first time that HCA-supplementation altered the expression of genes involved in lipolytic and adipogenic pathways in adipocytes from obese women and up-regulated the expression of serotonin receptor gene in the abdominal fat of rats. Similarly, we showed that NBC-supplementation up-regulated the expression of myogenic genes while suppressed the expression of genes that are highly expressed in brown adipose tissue in diabetic obese mice. The potential biological mechanisms underlying the observed beneficial effects of these supplements as elucidated by the state-of-the-art nutrigenomic technologies will be systematically discussed in this review.

Lau, Francis C; Bagchi, Manashi; Sen, Chandan; Roy, Sashwati; Bagchi, Debasis

2008-01-01

445

Nutrigenomic analysis of diet-gene interactions on functional supplements for weight management.  

PubMed

Recent advances in molecular biology combined with the wealth of information generated by the Human Genome Project have fostered the emergence of nutrigenomics, a new discipline in the field of nutritional research. Nutrigenomics may provide the strategies for the development of safe and effective dietary interventions against the obesity epidemic. According to the World Health Organization, more than 60% of the global disease burden will be attributed to chronic disorders associated with obesity by 2020. Meanwhile in the US, the prevalence of obesity has doubled in adults and tripled in children during the past three decades. In this regard, a number of natural dietary supplements and micronutrients have been studied for their potential in weight management. Among these supplements, (-)-hydroxycitric acid (HCA), a natural extract isolated from the dried fruit rind of Garcinia cambogia, and the micronutrient niacin-bound chromium(III) (NBC) have been shown to be safe and efficacious for weight loss. Utilizing cDNA microarrays, we demonstrated for the first time that HCA-supplementation altered the expression of genes involved in lipolytic and adipogenic pathways in adipocytes from obese women and up-regulated the expression of serotonin receptor gene in the abdominal fat of rats. Similarly, we showed that NBC-supplementation up-regulated the expression of myogenic genes while suppressed the expression of genes that are highly expressed in brown adipose tissue in diabetic obese mice. The potential biological mechanisms underlying the observed beneficial effects of these supplements as elucidated by the state-of-the-art nutrigenomic technologies will be systematically discussed in this review. PMID:19452041

Lau, Francis C; Bagchi, Manashi; Sen, Chandan; Roy, Sashwati; Bagchi, Debasis

2008-06-01

446

[Whey protein and creatine as nutritional supplements].  

PubMed

Nutritional supplements are very popular especially among athletes although some studies show either controversial or even negative results. However, whey protein and creatine seem to have positive effects on muscle size, strength and athletic performance without major adverse effects and high costs. Most studies have shown that supplementation of whey protein can enhance muscle growth in response to resistance training. Some studies also suggest that whey may enhance recovery from heavy exercise and possibly decrease muscle damage and soreness. Creatine supplementation increases the intracellular pool of phosphocreatine in skeletal muscle. Phosphocreatine provides a reserve of energy to rapidly regenerate ATP, which is consumed as a result of muscle contraction. Creatine has been studied in hundreds of clinical trials and has shown benefits including increased muscle strength, power and size. PMID:21553504

Sundell, Jan; Hulmi, Juha; Rossi, Jari

2011-01-01

447

Cognitive effects of creatine ethyl ester supplementation.  

PubMed

Supplementation with creatine-based substances as a means of enhancing athletic performance has become widespread. Until recently, however, the effects of creatine supplementation on cognitive performance has been given little attention. This study used a new form of creatine--creatine ethyl ester--to investigate whether supplementation would improve performance in five cognitive tasks, using a double-blind, placebo-controlled study. Creatine dosing led to an improvement over the placebo condition on several measures. Although creatine seems to facilitate cognition on some tasks, these results require replication using objective measures of compliance. The improvement is discussed in the context of research examining the influence of brain energy capacity on cognitive performance. PMID:19773644

Ling, Jonathan; Kritikos, Minos; Tiplady, Brian

2009-12-01

448

[Icariin and its pharmaceutical efficacy: research progress of molecular mechanism].  

PubMed

Icariin is one of the key active components of Epimedium species, which is most widely applied to supplement the kidney in traditional Chinese medicine. Scientific research has found that icariin possesses extensive therapeutic effects such as protecting neurons from injury, promoting growth of neuronal synapse, improving sexual dysfunction and bone morphogenesis, as well as anti-inflammation, anti-tumor and anti-depression functions. Considering that molecular mechanism is the fundamental basis for pharmaceutical efficacy of icariin, in this article, the authors retrospectively retrieved 122 scientific papers recorded in the PubMed database with "icariin" in the title from January 1, 1995 to January 5, 2011. It was found that icariin has been closely highlighted in the intervention of p38 mitogen-activated protein kinases and phosphatidylinositol 3-kinase/Akt signal pathways, inhibition of phosphodiesterase 5, and regulation of nuclear receptors. Besides, the authors also discussed the main orientation for molecular mechanism of icariin in future research. PMID:22088582

Chen, Yang; Huang, Jian-hua; Ning, You; Shen, Zi-yin

2011-11-01

449

Introduction: Minimally Invasive Spine Surgery video supplement.  

PubMed

This video supplement of Neurosurgery Focus is devoted to minimally invasive spine surgery. Minimally invasive spine surgery has gained popularity amongst patients and physicians over the past decade because it has been shown in select instances to lower blood loss and reduce length of hospital stay for appropriately selected candidates. This supplement includes videos from many of the leaders in the field. Pioneers like Frank LaMarca, Paul Park, Cheerag Upadhyaya, Juan Uribe, and Mike Wang have all sent in videos depicting minimally invasive spinal deformity surgery options. The supplement also includes videos from several different countries, demonstrating how widespread and nuanced minimally invasive spinal procedures have become. Drs. Barbagallo, Certo, Sciacca, and Albanese from Italy; Drs. Gragnaniello and Seex from Australia; and Drs. Liao, Wu, Huang, Wang, Chang, Cheng, and Shih from Taiwan have all sent in nuanced surgical videos that will be of interest to many viewers. I personally enjoyed viewing videos on lumbar degenerative disease surgery depicting unique surgical nuances to treat common problems. Dr. Beejal Amin, Dr. Harel Deutsch, Dr. Daniel Lu, and Dr. Adam Kanter have each submitted videos depicting lumbar decompression and/or fusion for lumbar degenerative stenosis and spondylosis. This supplement also included videos depicting the minimally invasive treatment of uncommon spinal pathologies as well. Videos from Dr. Fred Geisler, Dr. John O'Toole, and Dr. Noel Perin covered topics as varied as sacroiliac joint dysfunction, spinal arteriovenous malformations, and sympathetic chain surgery. I hope that you enjoy this issue of Neurosurgical Focus devoted to videos depicting the surgical nuances of minimally invasive spinal surgery. This video supplement has international appeal, and it has been an honor to be a guest editor on this superb supplement. PMID:23829838

Mummaneni, Praveen V

2013-07-01

450

Studies on the safety of creatine supplementation.  

PubMed

Doubtful allegations of adverse effects of creatine supplementation have been released through the press media and through scientific publications. In the present review we have tried to separate the wheat from the chaff by looking for the experimental evidence of any such claims. Anecdotal reports from athletes have appeared on muscle cramp and gastrointestinal complaints during creatine supplementation, but the incidence of these is limited and not necessarily linked to creatine itself. Despite several unproved allegations, liver (enzymes, urea) and kidneys (glomerular filtration urea and albumin excretion rates) show no change in functionality in healthy subjects supplemented with creatine, even during several months, in both young and older populations. The potential effects (production of heterocyclic amines) of mutagenicity and carcinogenicity induced by creatine supplementation have been claimed by a French Sanitary Agency (AFSSA), which might put consumers at risk. Even if there is a slight increase (within the normal range) of urinary methylamine and formaldehyde excretion after a heavy load of creatine (20 g/day) this is without effect on kidney function. The search for the excretion of heterocyclic amines remains a future task to definitively exclude the unproved allegation made by some national agencies. We advise that high-dose (>3-5 g/day) creatine supplementation should not be used by individuals with pre-existing renal disease or those with a potential risk for renal dysfunction (diabetes, hypertension, reduced glomerular filtration rate). A pre-supplementation investigation of kidney function might be considered for reasons of safety, but in normal healthy subjects appears unnecessary. PMID:21399917

Kim, Hyo Jeong; Kim, Chang Keun; Carpentier, A; Poortmans, Jacques R

2011-03-12

451

Effect of supplemental heat for nursing piglets.  

PubMed

The effect of absence or presence of supplemental heat for nursing piglets (a 250-watt lamp suspended 45 cm above the sleeping area for each litter) was studied from October to April in each of three successive winter seasons. Ambient room temperature was 21 C. Sows were fed a fortified corn-soybean meal diet and piglets did not have access to creep feed. Floors were constructed of either wood and expanded metal or steel slats and expanded metal combinations. In Exp. 1, piglets were given either no supplemental heat or a heat lamp from birth to 21 days. Percentages of piglets that died within the first 3 days were 13.4 and 4.4%, respectively. Total losses for the 21-day period were 18.5 and 11.0%, respectively. Average body weight gains were 3.50 kg for the unsupplemented piglets and 3.69 kg for the heat-supplemented piglets. In Exp. 2, 133 litters were used to evaluate the effects of the absence or presence of supplemental heat from day 3 postpartum. Supplemental heat was provided either from day 3 to day 6 or from day 3 to day 21. The control litters had no supplemental heat from day 3 to day 21. Neither sow feed consumption nor body weight change was significantly affected by treatment. Percentage death loss was not significantly affected by treatment, but piglet body weight gain was greater (p less than .01) when the heat lamp was used, for the total period. PMID:7390938

Adams, K L; Baker, T H; Jensen, A H

1980-05-01

452

Vitamin A supplementation modifies the association between mucosal innate and adaptive immune responses and resolution of enteric pathogen infections123  

PubMed Central

Background: The efficacy of vitamin A supplementation on diarrheal disease morbidity may reflect the divergent effects that supplementation has on pathogen-specific immune responses and pathogen-specific outcomes. Objective: We examined how vitamin A supplementation modified associations between gut-cytokine immune responses and the resolution of different diarrheal pathogen infections. Design: Stools collected from 127 Mexican children who were 5–15 mo old and enrolled in a randomized, placebo-controlled vitamin A supplementation trial were screened for enteropathogenic Escherichia coli (EPEC), enterotoxigenic E. coli (ETEC), and Giardia lamblia. Fecal concentrations of interleukin (IL)-6, IL-8, IL-4, IL-5, IL-10, monocyte chemoattractant protein 1 (MCP-1), tumor necrosis factor-? (TNF-?), and interferon-? (IFN-?) were measured by using an enzyme-linked immunosorbent assay. Hazard models that incorporated categorized cytokine variables (ie, nondetectable, less than the median of detectable concentrations, and at least the median of detectable concentrations) were fit to the length of pathogen infections stratified by treatment group. Results: Vitamin A–supplemented children with fecal MCP-1 or IL-8 concentrations less than the median of detectable concentrations and IL-10 concentrations of at least median concentrations had longer durations of EPEC infection than did children in the placebo group. In supplemented children, detectable fecal TNF-? or IL-6 concentrations were associated with shorter ETEC infection durations, whereas MCP-1 concentrations of at least the median were associated with longer infection durations. Children in this group who had IL-4, IL-5, or IFN-? concentrations of at least median detectable concentrations had shorter durations of G. lamblia infection. Conclusion: The effect of supplementation on associations between fecal cytokine concentrations and pathogen infection resolution depends on the role of inflammatory immune responses in resolving specific pathogen infections.

Santos, Jose Ignacio; Rosado, Jorge L; Estrada-Garcia, Teresa; Haas, Meredith; Al Mamun, Abdullah; DuPont, Herbert L; Nanthakumar, Nanda N

2011-01-01

453

Dietary Supplement Use Within a Multiethnic Population as Measured by a Unique Inventory Method  

Microsoft Academic Search

Use of dietary supplements is widespread, yet intakes from supplements are difficult to quantify. The Supplement Reporting study utilized a unique inventory method to quantify dietary supplement use across 1 year in a sample of 397 supplement users. Interviewers visited participants' homes in 2005-2006 to record supplement purchases and the number of pills in each supplement bottle every 3 months.

Suzanne P. Murphy; Lynne R. Wilkens; Kristine R. Monroe; Alana D. Steffen; Kim M. Yonemori; Yukiko Morimoto; Cheryl L. Albright

2011-01-01

454

Hypocitraturia despite potassium citrate tablet supplementation.  

PubMed

Citrate supplementation is widely used in the prevention of recurrent nephrolithiasis with hypocitraturia. Potassium citrate is the most commonly used citrate agent for this indication. In patients with chronic diarrheal syndromes, the absorption of potassium citrate can be affected. We describe a patient who presented with recurrent nephrolithiasis and chronic diarrhea and was found to have severe hypocitraturia despite citrate supplementation with potassium citrate tablets, likely due to inadequate gastrointestinal absorption of citrate from the slow-release wax-matrix tablets. PMID:17406150

Shenoy, Chetan

2006-07-13

455

Quality assurance issues in the use of dietary supplements, with special reference to protein supplements.  

PubMed

The use of dietary supplements is widespread in the general population, in athletes and recreational exercisers, and in military personnel. A wide array of supplements is available, but protein-containing products are consistently among the most popular, especially among those who engage in resistance training. There are significant risks associated with the use of unregulated dietary supplements. Risks include the absence of active ingredients, the presence of harmful substances (including microbiological agents and foreign objects), the presence of toxic agents, and the presence of potentially dangerous prescription-only pharmaceuticals. There is ample evidence of athletes who have failed doping tests because of the use of dietary supplements. There is also growing evidence of risks to health and of serious adverse events, including a small number of fatalities, as a result of supplement use. The risk associated with the use of protein powders produced by major manufacturers is probably low, and the risk can be further reduced by using only products that have been tested under one of the recognized supplement quality assurance programs that operate in various countries. Nevertheless, a small risk remains, and athletes, soldiers, and other consumers should conduct a cost-benefit analysis before using any dietary supplements. PMID:24027186

Maughan, Ronald J

2013-09-11

456

Dietary Supplement Polypharmacy: An Unrecognized Public Health Problem?  

PubMed Central

Excessive and inappropriate use of medications, or ‘polypharmacy’, has been recognized as a public health problem. In addition, there is growing use of dietary supplements in the United States; however, little is known about the patterns of supplement use. Recent reports in the literature of cases of excessive or inappropriate use of herbal dietary supplements leading to the term ‘polyherbacy’. The clinical vignettes described in this article highlight the need for further research on the nature and extent of multiple and inappropriate dietary supplement use or ‘dietary supplement polypharmacy’. Clinical interviewing and population surveys both address this issue in complementary ways, and provide a further understanding of dietary supplement use patterns.

Gryzlak, Brian M.; Zimmerman, M. Bridget; Wallace, Robert B.

2010-01-01

457

Vitamin D supplementation for women during pregnancy  

PubMed Central

Background Vitamin D deficiency or insufficiency is thought to be common among pregnant women. Vitamin D supplementation during pregnancy has been suggested as an intervention to protect against adverse gestational outcomes. Objectives To examine whether supplements with vitamin D alone or in combination with calcium or other vitamins and minerals given to women during pregnancy can safely improve maternal and neonatal outcomes. Search methods We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 October 2011), the International Clinical Trials Registry Platform (ICTRP) (31 October 2011), the Networked Digital Library of Theses and Dissertations (28 October 2011) and also contacted relevant organisations (8 April 2011). Selection criteria Randomised and quasi-randomised trials with randomisation at either individual or cluster level, evaluating the effect of supplementation with vitamin D alone or in combination with other micronutrients for women during pregnancy. Data collection and analysis Two review authors independently i) assessed the eligibility of studies against the inclusion criteria ii) extracted data from included studies, and iii) assessed the risk of bias of the included studies. Data were checked for accuracy. Main results The search strategy identified 34 potentially eligible references. We included six trials assessing a total of 1023 women, excluded eight studies, and 10 studies are still ongoing. Five trials involving 623 women compared the effects of vitamin D alone versus no supplementation/placebo and one trial with 400 women compared the effects of vitamin D and calcium versus no supplementation. Only one trial with 400 women reported on pre-eclampsia: women who received 1200 IU vitamin D along with 375 mg of elemental calcium per day were as likely to develop pre-eclampsia as women who received no supplementation (average risk ratio (RR) 0.67; 95% confidence interval (CI) 0.33 to 1.35). Data from four trials involving 414 women consistently show that women who received vitamin D supplements had higher concentrations of vitamin D in serum at term than those women who received no intervention or a placebo; however the magnitude of the response was highly heterogenous. Data from three trials involving 463 women suggest that women who receive vitamin D supplements during pregnancy less frequently had a baby with a birthweight below 2500 grams than those women receiving no treatment or placebo; statistical significance was borderline (RR 0.48; 95% CI 0.23 to 1.01). In terms of other conditions, there were no significant differences in adverse side effects including nephritic syndrome (RR 0.17; 95% CI 0.01 to 4.06; one trial, 135 women); stillbirths (RR 0.17; 95% CI 0.01 to 4.06; one trial, 135 women) or neonatal deaths (RR 0.17; 95% CI 0.01 to 4.06; one trial, 135 women) between women who received vitamin D supplements in comparison with women who received no treatment or placebo. No studies reported on preterm birth, maternal death, admission to neonatal intensive care unit/special nursery or Apgar scores. Authors' conclusions Vitamin D supplementation in a single or continued dose during pregnancy increases serum vitamin D concentrations as measured by 25-hydroxyvitamin D at term. The clinical significance of this finding and the potential use of this intervention as a part of routine antenatal care are yet to be determined as the number of high quality trials and outcomes reported is too limited to draw conclusions on its usefulness and safety. Further rigorous randomised trials are required to evaluate the role of vitamin D supplementation in pregnancy.

De-Regil, Luz Maria; Palacios, Cristina; Ansary, Ali; Kulier, Regina; Pena-Rosas, Juan Pablo

2013-01-01

458

EXECUTIVE SUMMARY Application Type NDA 19-845 NDA ...  

Center for Drug Evaluation (CDER)

Text Version... Timolol GFS 0.25% and 0.5% Therapeutic Classes beta-blockers Applicant Alcon Research, Ltd. Priority Designation P ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

459

WRITTEN REQUEST – AMENDMENT 1 NDA 20-864 NDA 20 ...  

Center for Drug Evaluation (CDER)

Text Version... parameters. The neurobehavioral tests must assess sensory function, motor function, and learning and memory. The neuropathological ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

460

Teacher Efficacy in Rural Zimbabwe  

ERIC Educational Resources Information Center

The need to address contextual variables, such as cultural bias and cultural norms, is a common challenge for researchers in international education. This article highlights societal conditions and cultural issues that could have impacted teacher efficacy data in Zimbabwe, a country known for its ongoing economic crisis, political repression, and…

Dunham, Judy K.; Song'ony, Daniel

2008-01-01

461

The Efficacy of Psychodynamic Psychotherapy  

ERIC Educational Resources Information Center

Empirical evidence supports the efficacy of psychodynamic therapy. Effect sizes for psychodynamic therapy are as large as those reported for other therapies that have been actively promoted as "empirically supported" and "evidence based." In addition, patients who receive psychodynamic therapy maintain therapeutic gains and appear to continue to…

Shedler, Jonathan

2010-01-01

462

Measuring protection: efficacy versus effectiveness.  

PubMed

In the clinical development of a vaccine, an efficacy study asks the question, "Does the vaccine work?" In contrast, an effectiveness study asks the question "Does vaccination help people?". In general, vaccine development proceeds from a study of immunogenicity to a randomized controlled trial that determines vaccine efficacy under ideal conditions. Efficacy studies, however, have several limitations. In an immunogenicity study, when a vaccine is given according to different schedules, the object of the study is not the vaccine itself but the schedules; i.e., what is important is not the "relative immunogenicity" of the vaccine, but which schedule is more protective given the occurrence of the disease that is to be prevented. Furthermore, a clinical trial of vaccine efficacy is unable to predict accurately the level of protection that will be achieved in public health practice. Vaccination effectiveness can be evaluated in a prospective clinical trial, although few such studies have been undertaken. Effectiveness is usually assessed retrospectively, sometimes using a screening test, but more often in a case-control or cohort study. In these studies, rigorous risk adjustment is necessary to ensure the comparability of study populations. Retrospective studies also provide a means for assessing serious but rare vaccine-associated adverse events, an undertaking often needed to maintain public confidence in vaccination programmes. Many vaccines currently under development will be replacement rather than new vaccines, and they are unlikely to be evaluated in traditional efficacy trials. In future years, effectiveness studies, some of them using large administrative databases, will become increasingly important features of vaccine development and the formulation of public policy for immunization. PMID:9855432

Fedson, D S

1998-01-01

463

An open label study on the supplementation of Gymnema sylvestre in type 2 diabetics.  

PubMed

Diabetes mellitus is a complex metabolic disorder characterized by chronic hyperglycemia, and associated with long-term damage and dysfunction of various organs. Management of diabetes is therefore vital and involves maintaining euglycemia as much as possible by reducing blood glucose and by increasing insulin sensitivity and peripheral glucose uptake. Ayurveda has promoted the management of diabetes by regulating carbohydrate metabolism using several medicinal herbs, one of which is Gymnema sylvestre (GS). GS has been used in parts of India as a hypoglycemic agent and the results have been encouraging. Accordingly, we planned a quasi-experimental study to investigate the efficacy of the herb among type 2 diabetics. Patients enrolled from free-living population were purposively assigned to experimental or control groups, based on their willingness to participate in the study. The experimental group was supplemented with 500 mg of the herb per day for a period of 3 months, and the efficacy of the herb was assessed through a battery of clinical and biochemical tests. Supplementation of the diet with GS reduced polyphagia, fatigue, blood glucose (fasting and post-prandial), and glycated hemoglobin and there was a favorable shift in lipid profiles and in other clinico-biochemical tests. These findings suggest a beneficial effect of GS in the management of diabetes mellitus. PMID:22432517

Kumar, Smriti Nanda; Mani, Uliyar Vitaldas; Mani, Indirani

2010-09-01

464

En Francasis: A Supplement of Classroom Activities.  

ERIC Educational Resources Information Center

|This classroom activity supplement is designed to accompany the "En Francais" language instruction series (programs 1-13) used on closed circuit television in South Carolina. It is intended to enrich classroom follow-up of the film program and to prvide a variety of activities and suggestions for teaching French language skills. Lessons introduce…

Enwall, Beverly; Joiner, Elizabeth

465

Herbal Supplements: Considerations for the Athletic Trainer  

PubMed Central

Objective: To examine common herbal supplements, explore potential risks associated with herbal use, and provide recommendations to the athletic trainer regarding patient care issues. Data Sources: We searched MEDLINE, SPORT Discus, CINAHL, and Academic Search Elite databases 1990–2000 using the key words herbals, regulation, supplements, toxicity, and adulteration. Data Synthesis: The use of herbal products continues to grow. While the origins of some medications and herbal supplements are similar, clinical testing and understanding of most herbal remedies is lacking. Some herbal products may prove useful in an athletic setting; however, current United States Food and Drug Administration (FDA) regulations do not ensure safe and effective products. A descriptive review focusing on specific considerations for the athletic trainer is provided. Conclusions/Recommendations: Despite their increasing tendency to seek natural therapies, athletes need to be aware that “natural” does not equal “safe.” Athletes are entitled to know that most herbs are not proven safe or effective under current FDA standards. The athletic trainer must be able to provide honest, unbiased information when educating athletes regarding herbal supplements.

Storrs, Cordial M.

2001-01-01

466

[Ma Huang, from dietary supplement to abuse].  

PubMed

Dietary supplements containing Ma Huang (chinease ephedra) are available on the web sites and dietary shops in USA. They are widely promoted and used as a mean of weight reduction and energy enhancement. They contain Ma Huang alone or combined with Guarana (caffeine), creatine, St John's wort, carnitine and are proposed with different labels. Numerous reports of adverse reactions and acute intoxication related to these products use were described in the medical literature. In the light of the severity of these cases, some of which resulted in permanent injury and death, the Food and Drug Administration has proposed limits on the dose and duration of use of such supplements. A review of 140 reports submitted to the FDA between June 1997 and March 1999, 47% involved cardiovascular symptoms, 18% neurological symptoms. Severe hypertension was the single most frequent adverse effect followed by tachycardia, myocardial infarction, stroke, seizure. Ten events resulted in death and 13 produced permanent impairment. In France, ampleness of the use of dietary supplements containing ephedra alkaloids is unknown. Two French recent severe poisonings (one with "ripped Fuel" for losing weight and the other with "Energy pills" in a body builder) show that there is serious health risks for the chronic users. Dietary supplements are not subject to control under "la Direction Générale de la Santé". Informations for general public, medical community and health-care authorities are necessary to be aware of potential health hazards of these products use. PMID:11974441

Arditti, J; Bourdon, J H; Spadari, M; de Haro, L; Richard, N; Valli, M

2002-01-01

467

Herbal Supplements: Considerations for the Athletic Trainer.  

ERIC Educational Resources Information Center

|Examines common herbal supplements, exploring potential risks associated with herbal use and providing recommendations to athletic trainers regarding patient care issues. Data from searches of the MEDLINE, SPORT Discus, CINAHL, and Academic Search Elite databases indicate that athletes must understand that natural does not equal safe, and most…

Winterstein, Andrew P.; Storrs, Cordial M.

2001-01-01

468

Creatine Supplementation and Exercise Performance Recent Findings  

Microsoft Academic Search

ments taken in an attempt to improve athletic performance. The aim of this review is to update, summarise and evaluate the findings associated with Cr ingestion and sport and exercise performance with the most recent research available. Because of the large volume of scientific literature dealing with Cr supplementation and the recent efforts to delineate sport-specific effects, this paper focuses

Michael G. Bemben; Hugh S. Lamont

469

Multivitamin Supplementation and Risk of Birth Defects  

Microsoft Academic Search

It is widely accepted that supplementation with folic acid, a B vitamin, reduces the risk of neural tube defects (NTDs). This case-control study tested the hypothesis that multivitamins reduce risks of selected birth defects other than NTDs. Infants with and without birth defects and aborted fetuses with birth defects were ascertained in the greater metropolitan areas of Boston, Philadelphia, and

Martha M. Werler; Catherine Hayes; Carol Louik; Samuel Shapiro; Allen A. Mitchell

470

Periconceptional folic acid containing multivitamin supplementation  

Microsoft Academic Search

Objective: A summary about the final results of the Hungarian double-blind placebo controlled randomised trial of periconceptional folic acid containing multivitamin and trace element supplementation. Results: The major finding is a significant prevention of the first occurrence of neural-tube defect, urinary tract and cardiovascular defects, in addition a decrease in the rate of limb deficiencies and congenital hypertrophic pyloric stenosis.

Andrew E. Czeizel

1998-01-01

471

Herbal Supplements: Considerations for the Athletic Trainer.  

ERIC Educational Resources Information Center

Examines common herbal supplements, exploring potential risks associated with herbal use and providing recommendations to athletic trainers regarding patient care issues. Data from searches of the MEDLINE, SPORT Discus, CINAHL, and Academic Search Elite databases indicate that athletes must understand that natural does not equal safe, and most…

Winterstein, Andrew P.; Storrs, Cordial M.

2001-01-01

472

INFORMATION COLLECTION RULE (ICR) SUPPLEMENTAL SURVEYS  

EPA Science Inventory

Resource Purpose: The primary purpose of the ICR Supplemental Surveys is to better characterize the occurrence of Cryptosporidium, Giardia, and other microorganisms and DBP precursors and to collect data pertaining to water quality parameters (pH, alkalinity, etc.) The inf...

473

How safe is vitamin E supplementation?  

PubMed

The safety of large doses of vitamin E went virtually unquestioned until the early 2000s, when several studies were published showing that consumption of vitamin E from dietary supplements increased mortality, as well as the risk of gastrointestinal cancer and heart failure. These studies prompted numerous letters to the editors of medical journals and widespread coverage in the media. Both the medical community and the general public became confused and concerned about the use of vitamin E supplements. The purpose of this article is to review the medical literature and to explain these unusual findings. First we provide an overview of the earlier literature on vitamin E. Second, we provide a critical assessment of three meta-analyses that were neutral or negative toward vitamin E supplementation. Third, we review the limitations of meta-analyses in general. Fourth, we assess the individual studies that comprised one of the three meta-analyses. Since all three meta-analyses used many of the same studies, the individual critique should further the understanding of the limitations of these meta-analyses, and the meta-analysis approach in general. Lastly, we offer some guidance for healthcare professionals to give to the general, healthy public and those with chronic conditions who are no doubt left puzzled as to what to do regarding vitamin E supplementation. PMID:18756398

Bell, Stacey J; Grochoski, Gregory T

2008-09-01

474

Supplementation of Wheat Gluten Protein1  

Microsoft Academic Search

Male weanling Wistar rats were fed diets containing wheat gluten (group 1), wheat gluten supplemented with lysine monohydrochloride (group 2), wheat gluten plus casein (group 3), casein (group 4), and egg albumin (group 5) as the dietary protein sources, as well as a diet free of protein (group 6). The nitrogen growth index of 8.6 for the group 1 animals

W. L. BANKS; J. B. ALLISON; R. W. WANNEMACHER

2010-01-01

475

Assessing Vitamin D Levels in Dietary Supplements  

Technology Transfer Automated Retrieval System (TEKTRAN)

Vitamin D is a nutrient of public health concern, particularly in the elderly, and is naturally present in some foods, added to others, and available as a dietary supplement. It is essential for bone growth and bone remodeling and recent research indicates it has other roles in human health, includi...

476

Food Service Worker. Supplemental Individualized Student Modules.  

ERIC Educational Resources Information Center

|Developed to supplement the food service worker modules published in 1977, this handbook provides fourteen additional individualized student modules. The topics included are as follow: (1) personal grooming; (2) safe handling of food and eating utensils; (3) setting up tables; (4) handling customers; (5) menus; (6) taking and placing the order;…

Hasty, Liswa E.; Bridwell, Terry B.